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

Coronary Artery Disease Clinical Trial

Official title:

Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00807040
• Other study ID #: GCO 08-1078-00002
• Secondary ID: U01HL088942U01 H
• Status: Completed
• Phase: Phase 2
• Start date: December 2008
• Est. completion date: March 2014

Study information

• Verified date: February 2019
• Source: Icahn School of Medicine at Mount Sinai
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Other known NCT identifiers

• NCT00919256

Recruitment information / eligibility

• Status: Completed
• Enrollment: 251
• Est. completion date: March 2014
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Mitral Valve Insufficiency
• Myocardial Ischemia

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Hôpital du Sacré-Coeur de Montréal	Montreal	Quebec
Canada	Montreal Heart Institute	Montreal	Quebec
Canada	Quebec Heart Institute/Laval Hopital	Quebec
United States	Mission Hospital	Asheville	North Carolina
United States	Emory University	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	NIH Heart Center at Suburban Hospital	Bethesda	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Montefiore Einstein Heart Center	Bronx	New York
United States	University of Virginia	Charlottesville	Virginia
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Duke University	Durham	North Carolina
United States	Inova Heart and Vascular Institute	Falls Church	Virginia
United States	East Carolina Heart Institute	Greenville	North Carolina
United States	University of Southern California	Los Angeles	California
United States	Wellstar Kennestone Hospital	Marietta	Georgia
United States	Columbia University Medical Center	New York	New York
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Research Institute	Plano	Texas
United States	Washington University	Saint Louis	Missouri

Sponsors (4)

Lead Sponsor	Collaborator
Icahn School of Medicine at Mount Sinai	Canadian Institutes of Health Research (CIHR), National Heart, Lung, and Blood Institute (NHLBI), National Institute of Neurological Disorders and Stroke (NINDS)

Countries where clinical trial is conducted

United States,  Canada, 

References & Publications (1)

Acker MA, Parides MK, Perrault LP, Moskowitz AJ, Gelijns AC, Voisine P, Smith PK, Hung JW, Blackstone EH, Puskas JD, Argenziano M, Gammie JS, Mack M, Ascheim DD, Bagiella E, Moquete EG, Ferguson TB, Horvath KA, Geller NL, Miller MA, Woo YJ, D'Alessandro D — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI)		Measured at Month 12
Secondary	All-cause Mortality		Measured at Month 24

External Links

•   Click here for the Cardiothoracic Surgical Trials Network Web site.