Phase 2
N=251
Comparing the Effectiveness of Repairing Versus Replacing the Heart's Mitral Valve in People With Severe Chronic Ischemic Mitral Regurgitation
Mitral Valve Insufficiency · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00807040 ↗Enrolled (actual)
251
Serious AEs
70.5%
Results posted
Jul 2017
Primary outcome: Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 54.6; 60.7 ml per square meter of body-surface area — p=0.18
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Mitral Valve Repair with Annuloplasty (Procedure); Mitral Valve Replacement (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Apr 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) |
54.6; 60.7 | 0.18 |
| SECONDARY All-cause Mortality |
24; 29 | 0.39 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00807040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.