Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
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Purpose
People with coronary artery disease (CAD) or people who have had a heart attack may develop a leak in the mitral valve of their heart and may therefore need to undergo surgery to fix the valve. The best way to fix the mitral valve remains undetermined. This study will evaluate whether it is better for people with severe mitral valve leakage to undergo a mitral valve replacement procedure or a mitral valve repair procedure.
| Condition | Intervention | Phase |
|---|---|---|
|
Mitral Valve Insufficiency Coronary Artery Disease |
Procedure: Mitral Valve Repair with Annuloplasty Procedure: Mitral Valve Replacement |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation |
- Degree of left ventricular remodeling, as assessed by left ventricular end systolic volume index (LVESVI) [ Time Frame: Measured at Month 12 ] [ Designated as safety issue: No ]
- All-cause mortality [ Time Frame: Measured at Month 24 ] [ Designated as safety issue: No ]
| Enrollment: | 251 |
| Study Start Date: | December 2008 |
| Estimated Study Completion Date: | June 2014 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Mitral Valve Repair with Annuloplasty
Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
|
Procedure: Mitral Valve Repair with Annuloplasty
The annuloplasty ring will be chosen by the surgeon. The ring is sized to the anterior leaflet and intertrigonal distance. A semi-rigid or rigid annuloplasty ring will be used, and if tethering is present, a subvalvar procedure will be performed.
|
|
Active Comparator: Mitral Valve Replacement
Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
|
Procedure: Mitral Valve Replacement
Mitral valve replacement will include complete preservation of the subvalvar apparatus. The technique of preservation, choice of prosthetic valve, and technique of suture placement will be dependent on the surgeon's preference. The prosthetic valve will be tested for paravalvular leaks by using the left ventricular saline infusion test.
|
Detailed Description:
CAD occurs when the arteries that supply blood to the heart become blocked as a result of plaque buildup. In severe cases, CAD can cause chest pain, shortness of breath, and heart attack. After a heart attack, some people may develop a leak in the mitral valve of the heart. This condition is known as ischemic mitral regurgitation (IMR), and it can cause blood to flow backward into the heart. If left untreated, severe IMR can lead to heart failure or serious heart rhythm irregularities, known as arrhythmias. People with severe mitral valve leakage routinely undergo one of two surgical procedures to fix the mitral valve: a mitral valve repair procedure, in which a surgical ring is used to repair the valve; or a mitral valve replacement procedure, in which the damaged valve is replaced with a new one. Currently, there is no consensus in the medical community as to which procedure is more beneficial. The purpose of this study is to determine whether people with severe mitral valve regurgitation should undergo a mitral valve repair procedure or a mitral valve replacement procedure.
This study will enroll people with CAD who have severe mitral regurgitation. At a baseline study visit, participants will undergo a physical examination; blood collection; neurocognitive tests; and questionnaires regarding medical history, medication history, and quality of life. In the operating room, participants will be randomly assigned to undergo either the mitral valve repair procedure or the mitral valve replacement procedure. Blood, urine, and tissue samples may be collected from participants after the surgery; this is optional and will only be done with prior approval from participants. All participants will attend study visits at Day 30 and Months 6, 12, and 24. At each visit, participants will take part in a medication history review, a physical examination, an echocardiogram, a cardiopulmonary exercise test, neurocognitive tests, and quality of life surveys.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Chronic severe ischemic mitral regurgitation (often with tethering as a major mechanism) in the judgment of the clinical site echocardiographer, assessed by transthoracic echocardiogram. Assessment of mitral regurgitation will be performed using an integrative method (Zoghbi W. et al. J. American Society of Echocardiography. 2003:16:777-802. see appendix). Quantitative guidelines as proposed would be: ERO ≥ 0.4 cmsq. If ERO < 0.4, then the degree of mitral regurgitation will be guided by other color Doppler quantitative methods (jet area/left atrial area ratio, vena contracta, supportive criteria in an integrated fashion
- Eligible for surgical repair and replacement of mitral valve
- CAD with or without the need for coronary revascularization
Exclusion Criteria:
- Any evidence of structural (chordal or leaflet) mitral valve disease or ruptured papillary muscle
- Prior mitral valve repair
- Severe irreversible pulmonary hypertension in the judgment of the investigator
- Medically unable to undergo cardiopulmonary bypass (CPB)
- Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
- Planned concomitant intra-operative procedures (with the exception of tricuspid valve repair, closure of patent foramen ovale [PFO] or atrial septal defect [ASD] or Maze procedure)
- Clinical signs of cardiogenic shock at the time of surgery
- Treatment with long-term intravenous inotropic therapy at the time of surgery
- ST segment elevation myocardial infarction (MI) requiring intervention in the 7 days before surgery
- Congenital heart disease (except PFO or ASD)
- Evidence of cirrhosis or liver synthetic failure
- Excessive surgical risk, as judged by the surgical investigator
- Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, as judged by the investigator
- Therapy with an investigational intervention at the time of screening, or planning to enroll in an additional investigational intervention study during participation in this study
- Any concurrent disease with a life expectancy of less than 2 years
- Pregnant
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00807040
| United States, California | |
| University of Southern California | |
| Los Angeles, California, United States, 90033 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30383 | |
| Wellstar Kennestone Hospital | |
| Marietta, Georgia, United States, 30060 | |
| United States, Maryland | |
| University of Maryland | |
| Baltimore, Maryland, United States, 21201 | |
| NIH Heart Center at Suburban Hospital | |
| Bethesda, Maryland, United States, 20892 | |
| United States, Massachusetts | |
| Brigham and Women's Hospital | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Missouri | |
| Washington University | |
| St Louis, Missouri, United States, 63110 | |
| United States, New York | |
| Montefiore Einstein Heart Center | |
| Bronx, New York, United States, 10467 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Mission Hospital | |
| Asheville, North Carolina, United States, 28801 | |
| Duke University | |
| Durham, North Carolina, United States, 27710 | |
| East Carolina Heart Institute | |
| Greenville, North Carolina, United States, 27834 | |
| United States, Ohio | |
| Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Pennsylvania | |
| University of Pennsylvania | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, Texas | |
| Baylor Research Institute | |
| Plano, Texas, United States, 75093 | |
| United States, Virginia | |
| University of Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Inova Heart and Vascular Institute | |
| Falls Church, Virginia, United States, 22042 | |
| Canada, Quebec | |
| Hôpital du Sacré-Coeur de Montréal | |
| Montreal, Quebec, Canada, QC H4J 1C5 | |
| Montreal Heart Institute | |
| Montreal, Quebec, Canada, H1T 1C8 | |
| Canada | |
| Quebec Heart Institute/Laval Hopital | |
| Quebec, Canada, H7M 3L9 | |
| Study Chair: | Timothy Gardner, MD | Christiana Care Health Services | |
| Study Chair: | Patrick O'Gara, MD | Brigham and Women's Hospital | |
| Principal Investigator: | Annetine C. Gelijns, Ph.D. | Mount Sinai School of Medicine |
More Information
Additional Information:
No publications provided by Mount Sinai School of Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Mount Sinai School of Medicine |
| ClinicalTrials.gov Identifier: | NCT00807040 History of Changes |
| Obsolete Identifiers: | NCT00919256 |
| Other Study ID Numbers: | GCO 08-1078-00002, U01HL088942, U01 HL088942-01-2, 595 |
| Study First Received: | December 10, 2008 |
| Last Updated: | April 4, 2014 |
| Health Authority: | United States: Federal Government Canada: Canadian Institutes of Health Research Canada: Ethics Review Committee |
Keywords provided by Mount Sinai School of Medicine:
|
Ischemic Mitral Regurgitation Mitral Valve Disease Severe Mitral Regurgitation |
Additional relevant MeSH terms:
|
Coronary Artery Disease Coronary Disease Mitral Valve Insufficiency Myocardial Ischemia Arterial Occlusive Diseases |
Arteriosclerosis Cardiovascular Diseases Heart Diseases Heart Valve Diseases Vascular Diseases |
ClinicalTrials.gov processed this record on February 27, 2015