Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Information provided by (Responsible Party):
Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT00807040
First received: December 10, 2008
Last updated: April 4, 2014
Last verified: April 2014
  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

Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
Criteria

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 Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00807040

Locations
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
Montreal Heart Institute
Montreal, Quebec, Canada, H1T 1C8
Hôpital du Sacré-Coeur de Montréal
Montreal, Quebec, Canada, QC H4J 1C5
Canada
Quebec Heart Institute/Laval Hopital
Quebec, Canada, H7M 3L9
Sponsors and Collaborators
Mount Sinai School of Medicine
Canadian Institutes of Health Research (CIHR)
Investigators
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
Myocardial Ischemia
Coronary Disease
Mitral Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Heart Valve Diseases

ClinicalTrials.gov processed this record on September 30, 2014