Frequently Asked Questions
Definition, Causes, and Symptoms of Mitral Regurgitation
01. What is mitral regurgitation?
02. What causes mitral regurgitation?
03. How does mitral regurgitation develop?
04. How common is mitral regurgitation?
05. What are the symptoms of mitral regurgitation?
06. What increases my risk of mitral regurgitation?
07. When should I see a doctor?
08. How will my doctor diagnose mitral regurgitation?
09. What is an echocardiogram?
10. What other heart valve disease is there?
11. How is mitral regurgitation treated?
12. Will I need any medication?
13. Will I need surgery?
Living with Mitral Regurgitation
14. Can I exercise with mitral regurgitation?
15. Should I have special concerns about antibiotics?
16. What are the risks associated with surgery for mitral regurgitation?
17. Is mitral regurgitation fatal?
18. Where else can I learn about mitral regurgitation?
EVEREST II Clinical Trial
19. What is a clinical trial?
20. What is the EVEREST II clinical trial?
21. What are the objectives of the EVEREST II clinical trial?
22. Who is sponsoring the EVEREST II clinical trial?
23. Which hospitals are participating in the EVEREST II clinical trial?
24. Am I eligible for participating in the EVEREST II clinical trial?
25. How long will the EVEREST II trial last?
26. How will patient safety be monitored in the EVEREST II trial?
27. How can I learn more about the EVEREST II trial?
Definition, Causes, and Symptoms of Mitral Regurgitation
What is mitral regurgitation?
Mitral regurgitation (MR) occurs when the leaflets (or flaps) of the heart’s mitral valve do not close properly and leak. The mitral valve is a one-way, blood flow regulator that separates the left atrium (a chamber in the heart which collects blood from the lungs) from the left ventricle (a chamber in the heart which pumps blood out to the body). During pumping, the leak causes blood to flow backwards (MR) into the left atrium, thereby decreasing blood flow to the body.
To compensate for MR, the left ventricle must pump harder. Backflow due to MR places an extra burden on the heart and lungs. Eventually, this extra burden can cause other problems such as:
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Progressive myocardial injury (ongoing and increasing damage to the heart muscle) |
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Congestive heart failure (a condition in which the heart is unable to maintain adequate circulation of blood in the body) |
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Stroke |
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Sudden death |
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Irregular heartbeat |
What causes mitral regurgitation?
Mitral regurgitation (MR) is usually caused by conditions that have damaged the heart’s mitral valve or weakened the heart muscle. Common causes of MR in adults are:
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Degeneration of the valve structure. |
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Heart attack (also called myocardial infarction) due to coronary artery disease (a condition, also known as arteriosclerosis, that reduces the blood flow through the coronary arteries to the heart muscle). |
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Injury to the mitral valve from infective endocarditis (an infection of the heart). |
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Valve damage from rheumatic fever. |
How does mitral regurgitation develop?
Mitral regurgitation (MR) is usually caused by conditions or incidents that weaken or damage the heart’s mitral valve. The most common causes of MR in adults are:
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Valve damage from rheumatic fever during childhood. |
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Injury to the mitral valve from a heart attack (also called myocardial infarction), or from coronary artery disease (a condition, also known as arteriosclerosis, that reduces the blood flow through the coronary arteries to the heart muscle). |
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Injury to the mitral valve from infective endocarditis (also called an infection of the heart). |
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Age. Normal “wear and tear”(“degeneration”) of the mitral valve over time may increase the likelihood of MR. |
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High blood pressure. High blood pressure can cause the left ventricle to encounter greater resistance as it pumps blood to the body. The increase in resistance ultimately places greater strain on the mitral valve and could cause MR. |
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Coronary Artery Disease, or CAD (build-up of plaque, or fatty substances, in the heart’s arteries), which can then cause clots to form, and obstruct blood flow. CAD may cause ischemia (reduced blood flow) or cardiomyopathy (disease of the heart muscle), which can affect the mitral valve's structure, leading to incomplete closure of the mitral valve and potential MR. |
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Marfan’s Syndrome (inherited disorder that causes problems in the connective tissues of the blood vessels, heart, and eyes) can lead to a calcification (hardening) of the mitral valve's base, which limits the mitral valve's flexibility and slows its rhythmic movements, and potentially increases the possibility of MR. |
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Mitral Valve Prolapse Syndrome (an abnormality of the mitral valve leaflets, or supporting chords, or both that forces the leaflets backwards into the left atrium) can cause the mitral valve to close improperly and may result in MR. |
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Rheumatic heart disease (a complication of untreated strep throat, or bacterial infection of the throat) can scar the heart’s valves, resulting in incomplete closure of the mitral valve and potential MR. |
How common is mitral regurgitation?
Chronic mitral regurgitation affects approximately 6% of women and 3% of men, but after 55 years of age, some degree of mitral regurgitation is found in almost 20% of men and women who undergo echocardiograms (also known as echo, and / or Doppler echocardiography) – an ultrasound test that produces an image of the heart and its valve functions.
What are the symptoms of mitral regurgitation?
The symptoms for mitral regurgitation (MR) vary, depending on the severity of a person’s condition. Therefore, it is important to have regular health exams with your doctor, in order to assess and follow your condition. Some people may never develop symptoms of MR. Other people may develop an enlarged left ventricle, because it is working harder to pump blood out to the body. Patients with severe chronic MR may have symptoms of congestive heart failure such as:
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Fatigue or inability to exercise |
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Decrease in appetite |
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Dry, hacking cough, often worse when lying down |
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Shortness of breath especially at night |
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Fainting or blacking out |
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Weight gain from fluid retention |
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Edema (accumulation of fluid) in feet, ankles and lungs |
What increases my risk of mitral regurgitation?
There are several risk factors for mitral regurgitation (MR), which include:
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Age. Normal “wear and tear”(“degeneration”) of the mitral valve over time may increase the likelihood of MR. |
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High blood pressure. High blood pressure can cause the left ventricle to encounter greater resistance as it pumps blood to the body. The increase in resistance ultimately places greater strain on the mitral valve and could cause MR. |
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Coronary Artery Disease, or CAD (build-up of plaque, or fatty substances, in the heart’s arteries), which can then cause clots to form, and obstruct blood flow. CAD may cause ischemia (reduced blood flow) or cardiomyopathy (disease of the heart muscle), which can affect the mitral valve's structure, leading to incomplete closure of the mitral valve and potential MR. |
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Marfan’s Syndrome (inherited disorder that causes problems in the connective tissues of the blood vessels, heart, and eyes) can lead to a calcification (hardening) of the mitral valve's base, which limits the mitral valve's flexibility and slows its rhythmic movements, and potentially increases the possibility of MR. |
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Mitral Valve Prolapse Syndrome (an abnormality of the mitral valve leaflets, or supporting chords, or both that forces the leaflets backwards into the left atrium) can cause the mitral valve to close improperly and may result in MR. |
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Rheumatic heart disease (a complication of untreated strep throat, or bacterial infection of the throat) can scar the heart’s valves, resulting in incomplete closure of the mitral valve and potential MR. |
When should I see a doctor?
If you believe you are experiencing symptoms (see Symptoms of Mitral Regurgitation), you should see your doctor immediately.
How will my doctor diagnose mitral regurgitation?
To diagnose MR, your doctor needs to make several assessments. First, s/he will need to determine whether the MR is chronic (present for a long time) or acute (sudden/recent development). Your doctor will need to assess its severity and check for any other complications or influencing conditions. To make these decisions, your doctor may:
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Ask you about your medical history |
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Conduct a physical exam |
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Order tests for you to undergo |
Your doctor may also perform a physical exam: take your blood pressure, check your pulse, listen to your heart and lungs, and examine your feet and legs for signs of excess fluid.
Finally, your doctor may order tests, to identify any abnormal heart function. These tests might include:
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An echocardiogram (also known as echo, and/or Doppler echocardiography) – an ultrasound that produces an image of the heart and its valves. |
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In some cases, your doctor may request coronary angiography (also called cardiac catheterization) – a diagnostic test where a solution (also known as contrast) is injected into the coronary arteries, which enables fluoroscopy (or an x-ray machine) to trace the movement of blood and assess the ejection fraction (the amount of blood pumped out of a ventricle during each heartbeat). A catheter (tiny flexible tube) is inserted into a blood vessel in the arm or groin, and then threaded through to the heart and its chambers. When the catheter enters the heart chamber, it can inject dye to trace the movement of blood and thereby assess the mitral valve function. |
What is an echocardiogram?
An echocardiogram (also known as ECG, and / or Doppler echocardiography) is an ultrasound test that produces an image of the heart and its valves.
What other heart valve disease is there?
The heart has four valves: the pulmonary valve, the aortic valve, the tricuspid valve, and the mitral valve. When functioning properly, the four heart valves ensure sure that blood always flows in a forward direction, without backward leakage. There are several types of heart valve disease:
Valvular stenosis (narrowing of opening). This occurs when a heart valve opening is smaller than normal, due to stiff or fused leaflets (flaps). The narrowed opening causes the heart to work hard to pump blood through it. This increased exertion can lead to heart failure, or other heart problems. All four valve openings can become narrowed restricting blood flow). The conditions are called pulmonic stenosis, aortic stenosis, tricuspid stenosis and mitral stenosis.
Valvular insufficiency. Also called regurgitation, incompetence or "leaky valve", this occurs when a valve does not close properly. If the valve does not seal, some blood will leak backwards across the valve. As the leak worsens, the heart has to work harder to make up for the leaky valve, and less blood may flow to the rest of the body. Depending on which valve is affected, the valvular insufficiency is called: pulmonary regurgitation, aortic regurgitation, tricuspid regurgitation or mitral regurgitation.
How is mitral regurgitation treated?
Medical Treatment
There are no medications that are proven to effectively treat mitral regurgitation (MR), but there are medications that are used to treat its associated symptoms. For patients diagnosed with either Grade 1 (mild) or Grade 2 (moderate) MR, ongoing monitoring of their MR condition, along with treatment of its symptoms, may be sufficient. Drugs that are used to treat symptoms of MR include:
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Diuretics (drugs that help promote body fluid loss through urination) can help to relieve fluid accumulation in your lungs or legs. |
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Blood pressure medications. Since high blood pressure can worsen MR, your doctor may prescribe medication to help lower your blood pressure. There are many types of blood pressure medication: beta blockers (which reduce heartrate and the heart’s output of blood) and vasodilators / ACE inhibitors / calcium channel blockers (which open up narrowed blood vessels). |
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Antibiotics (drugs which kill bacteria) are used to help prevent or treat endocarditis (infection of the heart’s inner lining or the heart valves). |
For symptomatic patients diagnosed with either Grade 3 (moderate to severe) or Grade 4 (severe) MR, surgery is generally recommended to repair or replace the mitral valve. The American College of Cardiology and the American Heart Association also recommend mitral valve surgery (repair or replacement), if the patient’s ejection fraction (the amount of blood pumped out of the left ventricle during each heartbeat) drops below 60%, or if the patients left ventricle is larger than 45 millimeters at rest even if you have no symptoms.
Mitral valve repair or replacement requires hospitalization and involves open-heart surgery, which usually lasts several hours. A patient is placed under general anesthesia for the entire operation. The heart surgeon makes an incision into the patient’s chest. Blood is circulated through a heart-lung machine, which adds oxygen to the blood and maintains stable blood flow. The patient’s heart is stopped to facilitate the surgery. The mitral valve is either removed and replaced with a mechanical (artificial) heart valve or repaired.
Mitral Valve Repair
Mitral valve repair is usually preferable to mitral valve replacement. Mitral valve repair is accomplished using one or more of the following techniques:
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Resection. This surgical technique involves remodeling of the mitral valve by removing some portion of the leaflet tissue. |
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Annuloplasty. This procedure involves implanting a ring (collar-like structure) around the mitral valve’s base, in order to remodel the opening (annulus) to support the repair. |
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Edge to Edge (or E2E), or Double Orifice Repair. In this procedure, the leaflets of the mitral valve are co-apted (or joined / brought together), in order to form a double orifice (two openings) in the mitral valve. |
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Chordal Transposition. This procedure involves re-attaching the chordae tendineae (the fibers that connect to muscles in the left ventricle and that control movement of the mitral valve leaflets) to the mitral valve. |
Mitral Valve Replacement
For patients with a hard, calcified annulus (mitral valve base) or widespread damage to the mitral valve and its surrounding tissue, replacement of the mitral valve is usually recommended. The damaged mitral valve is replaced with a mechanical (plastic or metal) valve, or a bio-prosthetic valve (either from a human cadaver, or from pig or cow tissue). The damaged mitral valve is removed and the new valve is sewn into place.
Mechanical mitral valves have greater durability than tissue or bio-prosthetic valves, but patients who receive them must take anticoagulants (medications which thin the blood and reduce the likelihood of blood clotting) on a permanent basis. However, there are risks associated with anticoagulants, which include increased risk of bleeding, drop in level of blood cells, dizziness, headache, stroke, etc.
Will I need any medication?
See - How is mitral regurgitation treated?
Patients who undergo mitral valve surgery will require medication. Often, antibiotics are prescribed, in order to minimize the risk of surgical infection. Usually in cases of mitral valve replacement, anticoagulants (blood-thinning drugs) are required, in order to reduce the risk of blood clotting and the potential for stroke (a rupture or obstruction of a blood vessel of the brain that can cause loss of consciousness, sensation, and voluntary motion).
Will I need surgery?
If patients are diagnosed with either Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), surgery may be required to repair or replace the mitral valve. Your physician will be able to recommend the appropriate treatment.
Living with Mitral Regurgitation
Can I exercise with mitral regurgitation?
If diagnosed with mitral regurgitation, you should consult your doctor about safe health habits, including exercise and nutrition.
Should I have special concerns about antibiotics?
Many people use and benefit from taking antibiotics. However, in some cases, and with certain antibiotics, some people develop side effects or allergic reactions. To learn more about antibiotics, you should ask your doctor about which specific medications are prescribed to you, so that you can learn more about it.
What are the risks associated with surgery for mitral regurgitation?
Mitral valve repair or replacement requires hospitalization and involves open-heart surgery, which usually lasts several hours or more. A patient is placed under general anesthesia for the entire operation. The heart surgeon makes an incision into the patient’s chest. Blood is circulated through a heart-lung machine, which adds oxygen to the blood and maintains stable blood flow. The patient’s heart is stopped to facilitate the surgery. The mitral valve is either removed and replaced with a prosthetic (artificial) heart valve or repaired.
Is mitral regurgitation fatal?
If left untreated, mitral regurgitation (MR) can result in death, in some cases. If you believe you are experiencing symptoms (please refer to Causes and Symptoms of MR) of MR, you should consult your doctor.
Where else can I learn about mitral regurgitation?
Medline Plus
http://www.nlm.nih.gov/medlineplus/ency/article/000176.htm
Mayo Clinic.com
http://www.mayoclinic.com/invoke.cfm?id=DS00421
Web MD
http://my.webmd.com/hw/heart_disease/aa143445.asp
http://my.webmd.com/hw/heart_disease/aa143456.asp
CNN.com Health
http://www.cnn.com/HEALTH/library/DS/00421.html
Heart Center Online
http://www.heartcenteronline.com/The_Heart_Valve_Center.html?WT.srch=1
Peace Health
http://www.peacehealth.org/kbase/topic/special/aa143442/sec1.htm
EVEREST II Clinical Trial
What is a clinical trial?
A clinical trial is a research study that tests new drugs, medical devices or other instruments, or medical procedure procedures or drugs on people.
What is the EVEREST II clinical trial?
Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices to enable percutaneous repair of cardiac valves. The company’s initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. The company’s present development and clinical efforts are focused on mitral valve repair.
Evalve, Inc. is sponsoring a Phase II IDE clinical trial, called EVEREST II (an acronym for Endovascular Valve Edge-to-Edge REpair STudy). The purpose of this clinical trial is to assess the safety and efficacy (or effectiveness) of the Evalve procedure in treating patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation MR, as compared to surgical repair of MR.
Patients with Grade 3 or Grade 4 MR will be enrolled into the EVEREST II trial. To ensure that the results of the EVEREST II trial are unbiased, participants will be randomly assigned to either the Evalve procedure or to surgery, in a “two-to-one” ratio. This means that two out of 3 of trial participants will undergo the Evalve procedure and one out of 3 of participants will undergo mitral valve surgery. EVEREST II trial participants will be required to have a number of follow-up visits and evaluations including ultrasound studies over the course of a 24-month period, starting in early 2005. These follow up visits are intended to monitor the outcome of the procedure. Depending on the course of the study, the FDA (Food and Drug Administration) may also extend the follow-up period of this study for up to five years or longer.
What are the objectives of the EVEREST II clinical trial?
The purpose of the Evalve EVEREST II Phase II clinical trial is to assess the safety and effectiveness of the Evalve procedure in treating patients diagnosed with Grade 2 (moderate), Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), as compared to surgical repair of MR.
Who is sponsoring the EVEREST II clinical trial?
Evalve, Inc. is sponsoring a Phase II IDE clinical trial, called EVEREST II (an acronym for Endovascular Valve Edge-to-Edge REpair STudy). The purpose of this clinical trial is to assess the safety and efficacy (or effectiveness) of the Evalve procedure in treating patients diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation MR, as compared to surgical repair of MR.
Evalve was incorporated in 1999 to design, develop, manufacture and market innovative devices, which enable the percutaneous repair of cardiac valves. The company’s initial products are intended to reduce the risks, trauma and costs associated with current open, arrested heart surgical options. The company’s present development and clinical efforts are focused on mitral valve repair.
Which hospitals are participating in the EVEREST II clinical trial?
The EVEREST II study will take place in several medical centers located throughout the
Evanston Northwestern Healthcare
2650 Ridge Ave., Burch 300
Evanston, IL 6020
Ted Feldman, MD (EVEREST II CO-Principal Investigator)
Interventional Cardiologist
Beth Garnier, RN (Coordinator)
Phone: (847) 570-1997
Email: egarnier@enh.org
Hospital of the University of Pennsylvania
9 Founders Pavilion
3400 Spruce St.
Philadelphia, PA 19104
Howard C. Herrmann, MD (Investigator)
Director, Interventional Cardiology, Cardiac Cath Labs
Phone: (215) 662-2180
Email: howard.herrmann@uphs.upenn.edu
The Cleveland Clinic Foundation
Dept.of Cardiovascular Medicine
F25 9500 Euclid Avenue
Cleveland, OH 44195
Patrick Whitlow, MD (Investigator)
Interventional Cardiologist
Kelly Brezina, RN (Coordinator)
Phone: (216) 445-6820
Email: brezink@ccf.org
Emory University
1364 Clifton Road NE, Suite F606
Atlanta, GA 30322
Ziyad Ghazzal, MD (Investigator)
Interventional Cardiologist
Pamela Hyde, RN (Coordinator)
Phone: (404) 712-7665
Email: pamela.hyde@emoryhealthcare.org
Swedish Medical Center
1st Hill Campus 747 Broadway
Seattle, WA 98122-4307
Mark Reisman, MD (Investigator)
Director, Cardiac Catheterization Laboratory
Tracie Granger (Coordinator)
Phone: (206) 215-2466
Email: tracie.granger@swedish.org
Washington Hospital Center
110 Irving St., NW
Washington, DC 20010
Kenneth Kent, MD (Investigator)
Interventional Cardiologist
Petros Okubagzi, MD (Coordinator)
Phone: (202) 877-2146
Email: pokubagzi@gmail.com
Columbia University Medical Center
177 Fort Washington Avenue
New York, NY 10032
William Gray, MD (Investigator)
Interventional Cardiologist
Miriam Lucca-Susana (Coordinator)
Phone: (212) 305-7061
Email: ml654@columbia.edu
University of Texas Science Health Center
Department of Medicine Cardiology, 7703 Floyd Curl Drive
San Antonio, TX 78229
Steven R. Bailey, MD (Investigator)
Interventional Cardiologist
Joyce T. Holubec, RN (Coordinator)
Phone: (210) 567-6553
Email: holubec@uthscsa.edu
Shawnee Mission Medical Center
7301 E. Frontage Rd., Suite 200
Shawnee Mission, KS 66204
Paul Kramer, MD (Investigator)
Interventional Cardiologist
Nancy Hayek-Cobb, MS, RN, BSN, CCRA (Coordinator)
Phone: (913) 676-8185
Email: nhayek-cobb@kcheart.com
Carolina's Medical Center (Sanger Clinic)
1000 Blythe Blvd.
Charlotte, NC 28203
Michael J. Rinaldi, MD (Investigator)
Interventional Cardiologist
Gale Schwarz, RN, CCRC (Coordinator)
Phone: (704) 355-4797
Email: gale.schwarz@carolinashealthcare.org
Duke University Medical Center
Room 7324, Duke Hospital North, Erwin Road
Durham, NC 27710
Andrew Wang, MD (Investigator)
Associate Professor of Medicine
Donald Glower, MD (EVEREST II Co-Principal Investigator)
Cardiothoracic Surgeon
Dana Glisson, RN (Coordinator)
Phone: (919) 681-3810
Email: dana.glisson@duke.edu
Brigham and Women's Hospital
1620 Tremont St.
Boston, MA 02120
Andy Eisenhauer, MD (Investigator)
Interventional Cardiologist
Denise Cinamon, RN (Coordinator)
Phone: 617-732-7831
Email: dcinamon@partners.org
Memorial Hermann Hospital
University of Texas Health Sciences Center at Houston
6431 Fannin, Ste. 1246
Houston, TX 77225
Richard Smalling, MD (Investigator)
Interventional Cardiologist
Mary Vooletich, RN (Coordinator)
Phone: 713-500-6550
Email: mary.vooletich@uth.tmc.edu
University of Colorado Health Sciences Center
4200 E. 9th Avenue, Campus Box B-132
Denver, CO 80262
John D. Carroll, MD, FACC (Investigator)
Chief of Cardiology, UCH
Director, Cardiac and Vascular Center
University of Colorado Hospital
Professor of Medicine, UCHSC
Kathy Kioussopoulos, RN (Coordinator)
Phone: (303) 372-6648
Email: kathy.kioussopoulos@uchsc.edu
Nebraska Heart Institute
7440 S 91st Street
Lincoln, NE 68526
Vishwajeth Bhoopalam, MD (Investigator)
Interventional Cardiologist
Amy Akins, RN (Coordinator)
Phone: (402) 483-8619
Email: aakins@neheart.com
St. Francis Hospital
100 Port Washington Blvd
Roslyn, NY 11576
Andrew D. Berke, MD (Investigator)
Interventional Cardiologist
Aracey Norales, RN, ANP (Coordinator)
Phone: (516) 562-6904
Email: aracely.norales@chsli.org
Terrebonne General Medical Center
8120 Main Street, Suite 100
Houma, LA 70360
Peter S. Fail, MD (Investigator)
Interventional Cardiologist
Stacy Henry, RN (Coordinator)
Phone: (985) 850-6301
Email:stacy.henry@tgmc.com
The Care Group at The Heart Center
10590 N. Meridian, Suite 300
Indianapolis, IN 46260
James Hermiller, MD (Investigator)
Director, Cardiac Catheterization Laboratory
Anne Taylor, RN (Coordinator)
Phone: (317) 583-6319
Email: ataylor@thecaregroup.com
UCD Medical Center
2315 Stockton Blvd, Suite #6312
Sacramento, CA 95817
Reginald Low, MD (Investigator)
Chief of Cardiovascular Medicine
Jason Rogers, MD (Investigator)
Interventional Cardiologist
Kimberley Book, RN (Coordinator)
Phone: (916) 734-5639
Email: kimberley.book@ucdmc.ucdavis.edu
Cedars-Sinai Medical Center
8700 Beverly Blvd
Los Angeles, CA 90048
Saibal Kar, MD (Investigator)
Director of Interventional Cardiac Research
Asma Hussaini, PA-C (Coordinator)
Phone: (310) 423-2658
Email: hussainia@cshs.org
Washington University Medical Center
660 S. Euclid Ave. Box 8086
St. Louis, MO 63110
John Lasala, MD, Phd (Investigator)
Interventional Cardiologist
Kim Striler, RN, MSN (Coordinator)
Phone: (314) 747-4452
Email: kzuchows@im.wustl.edu
University of Virginia
UVA Cardiology, Box 800158
Charlottesville, Virginia 22908
Scott Lim, MD (Investigator)
Interventional Cardiologist
Linda Bailes, RN (Coordinator)
Phone: (434) 982-1058
Email: lgs2m@virginia.edu
Toronto General Hospital
200 Elizabeth St. 12en 236
Toronto, Ontario M5G 2C4 CANADA
Leonard Schwartz, MD (Investigator)
Interventional Cardiologist
Eric Horlick, MD (Investigator)
Interventional Cardiologist
Rachael Ramsamujh, RN (Coordinator)
Phone: (416) 340-4800 x6153
Email: rachael.ramsamujh@uhn.on.ca
Banner Good Samaritan Hospital
1111 E. McDowell Rd., Ancillary II - Room 2022
Phoenix, AZ 85006
Tim Bryne, MD (Investigator)
Interventional Cardiologist
Pam Thompson, RN, BSN, CCRC (Coordinator)
Phone: (602) 239-5678
Email: Pam.Thompson@bannerhealth.com
St. Luke's Medical Center
2900 W. Oklahoma Avenue
Milwaukee, WI 53215
Tanvir Bajwa, MD (Investigator)
Interventional Cardiologist
Ann Hintz, RN (Coordinator)
Phone: (414) 385-2459
Email: ann.hintz@aurora.org
Ochsner Clinic Foundation
1514 Jefferson Highway, 3E316
560 First Avenue
New Orleans, LA 70121
Stephen R. Ramee, MD (Investigator)
Interventional Cardiologist
Barbara Hirstius, RN (Coordinator)
Phone: (504) 842-4833
Email: bhirstius@ochsner.org
New York University Medical Center
NYU Medical Ctr. Cardiac Cath Lab, TCH 576
560 First Avenue
New York, NY 10016
James Slater, MD (Investigator)
Interventional Cardiologist
Elise Weisman, RN (Coordinator)
Phone: (212) 263-2188
Email: wilnee01@nyumc.org
Baylor University Medical Center
Baylor Heart and Vascular Institute
621 N. Hall Street, Suite H030
Dallas, TX 75226
Paul Grayburn, MD (Investigator)
Interventional Cardiologist
Susan Aston, RN (Coordinator)
Phone: (214) 820-7358
Email: susanas@baylorhealth.edu
St. Joseph Mercy Heart
5301 E. Huron River Drive
Ypsilanti, MI 48197
Michael J. O'Donnell, MD (Investigator)
Interventional Cardiologist
Jennifer Piper, RN (Coordinator)
Phone: (734) 712-7602
Email: jpiper@michiganheart.com
New York Presbyterian Hospital
The University Hospital of Columbia Cornell
Cardiac Catheterization Laboratory
New York Weill Cornell Center
525 East 68th Street, F-433/F-439
New York, NY 10021
S. Chiu Wong, MD (Investigator)
Interventional Cardiologist
Dolores T. Reynolds, RN, BSN (Coordinator)
Phone: (212) 746-4617
Email: dtr2001@med.cornell.edu
Adriano Vitale, RN (Coordinator)
Phone: (212) 746-4620
Email: adv2003@med.cornell.edu
Victoria Heart Institute Foundation
1900 Richmond Avenue, Suite 200
Victoria, BC V8R 4R2, Canada
Eric Fretz, MD (Investigator)
Interventional Cardiologist
Liz Reimer, RN (Coordinator)
Phone: (250) 595-1884
Email: ereimer@vhif.org
Am I eligible for participating in the EVEREST II clinical trial?
If you are interested in participating in EVEREST II, please discuss this with your doctor, contact an investigational site (link to site list) in your region or Evalve, Inc. (www.evalveinc.com).
The EVEREST II trial investigators are seeking to enroll patients who have been diagnosed with Grade 3 (moderate to severe) or Grade 4 (severe) mitral regurgitation (MR), who are seeking treatment for their condition and who:
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Are at least 18 years or older |
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Are candidates for mitral valve surgery |
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Do not have an active peptic ulcer (a hole in the lining of the stomach, the duodenum – first part of the small intestine – or the esophagus, the tube that connects the throat to the stomach), nor have experienced bleeding in the upper gastro-intestinal tract, within the last six months. |
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Do not require dialysis (process of cleansing the blood, by passing it through a machine) |
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Do not have a history of intravenous drug abuse (drugs injected into the veins) |
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Do not have allergies or hypersensitivity to aspirin, heparin (anti-blood-clotting medication), Ticlid (anti-blood-clotting medication) , Plavix (anti-blood-clotting medication), or contrast media (dye used in X-rays) |
How long will the EVEREST II trial last?
EVEREST II trial participants will participate in a number of associated tests, procedures and follow-up visits over the course of a 24-month period, starting in early 2005.
How will patient safety be monitored in the EVEREST II trial?
The rights and safety of clinical trial patients are protected in several important ways. First, every clinical trial must be designed and conducted with the approval and oversight of an Institutional Review Board (IRB) or ethics committee. The IRB is comprised of both physicians and lay people, and is responsible for reviewing and assessing the clinical trial’s protocols (e.g., detailed plans), in order to protect patients’ rights and safety.
Equally important, prospective clinical trial participants are required to sign an "informed consent" form, which provides detailed information regarding the purpose and objectives of the clinical trial, the risks involved in the trial, and potential effects and risks of the trial on patients. All trial participants have the right to leave the trial whenever they wish.
A Data Safety Monitoring Board (DSMB) is set up for additional patient safety as well. A DSMB is a group of experts who meet periodically to review accumulated information (data) gathered from participants in clinical trials with the purpose of protecting
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the safety of the study subjects (patient) |
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the scientific integrity of the study |
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the validity of study results |
A DSMB is made up of people external to the study group. The members of the Board
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are independent of the sponsor of the study and of the manufacturer of any product that is being evaluated |
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have no financial interest in whether the study they are monitoring continues |
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receive no scientific recognition in the form of publications or promotions from the results |
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have relevant expertise (clinical, statistical, and/or study design) |
How can I learn more about the EVEREST II trial?
To learn more about the EVEREST II clinical trial, please visit www.evalveinc.com or contact one of the research sites.