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

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ClinicalTrials.gov Identifier: NCT00807040
Recruitment Status : Completed
First Posted : December 11, 2008
Results First Posted : July 31, 2017
Last Update Posted : March 15, 2019
Sponsor:
Collaborators:
National Heart, Lung, and Blood Institute (NHLBI)
Canadian Institutes of Health Research (CIHR)
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Alan Moskowitz, Icahn School of Medicine at Mount Sinai

Tracking Information
First Submitted Date  ICMJE December 10, 2008
First Posted Date  ICMJE December 11, 2008
Results First Submitted Date  ICMJE May 26, 2017
Results First Posted Date  ICMJE July 31, 2017
Last Update Posted Date March 15, 2019
Study Start Date  ICMJE December 2008
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) [ Time Frame: Measured at Month 12 ]
Original Primary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
The primary outcome is the degree of left ventricular remodeling, as assessed by Left Ventricular End Systolic Volume Index (LVESVI) at 12 months [ Time Frame: 12 months ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 19, 2008)
All-cause Mortality [ Time Frame: Measured at Month 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: December 10, 2008)
The primary secondary outcome measure is all-cause mortality. [ Time Frame: 24 months ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Official Title  ICMJE Evaluation of Outcomes Following Mitral Valve Repair/Replacement in Severe Chronic Ischemic Mitral Regurgitation
Brief 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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Mitral Valve Insufficiency
  • Coronary Artery Disease
Intervention  ICMJE
  • 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.
  • 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.
Study Arms  ICMJE
  • Active Comparator: Mitral Valve Repair with Annuloplasty
    Participants will undergo mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering.
    Intervention: Procedure: Mitral Valve Repair with Annuloplasty
  • Active Comparator: Mitral Valve Replacement
    Participants will undergo mitral valve replacement and complete preservation of the sub-valvular apparatus.
    Intervention: Procedure: Mitral Valve Replacement
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 10, 2013)
251
Original Estimated Enrollment  ICMJE
 (submitted: December 10, 2008)
250
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date April 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00807040
Other Study ID Numbers  ICMJE GCO 08-1078-00002
U01HL088942 ( U.S. NIH Grant/Contract )
U01 HL088942-01-2
595 ( Other Identifier: Ct Surgery Network Research Group )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Alan Moskowitz, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Icahn School of Medicine at Mount Sinai
Collaborators  ICMJE
  • National Heart, Lung, and Blood Institute (NHLBI)
  • Canadian Institutes of Health Research (CIHR)
  • National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
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. Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date February 2019

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