N/A
N=301
Comparing the Effectiveness of a Mitral Valve Repair Procedure in Combination With Coronary Artery Bypass Grafting (CABG) Versus CABG Alone in People With Moderate Ischemic Mitral Regurgitation
Mitral Valve Insufficiency · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT00806988 ↗Enrolled (actual)
301
Serious AEs
55.5%
Results posted
Jun 2017
Primary outcome: Primary: Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) — 49.6; 46.1 ml per square meter — p=0.61
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mitral Valve Repair (Procedure); CABG (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- May 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Degree of Left Ventricular Remodeling, as Assessed by Left Ventricular End Systolic Volume Index (LVESVI) |
49.6; 46.1 | 0.61 |
| SECONDARY Major Adverse Cardiac Event, Including Death, Stroke, Worsening Heart Failure (+1 New York Heart Association [NYHA] Class), Congestive Heart Failure Hospitalization, or Mitral Valve Re-intervention |
46; 48 | 0.83 |
Summary
Coronary artery bypass grafting (CABG) is a procedure that people with coronary artery disease (CAD) may undergo to increase blood flow to the heart. During a CABG procedure, people who have a leak in one of the valves in the heart-the mitral valve-may at the same time undergo a procedure that repairs the valve. This study will evaluate whether people with moderate mitral valve leakage would be better off undergoing CABG plus the mitral valve repair procedure or undergoing CABG alone.
Eligibility Criteria
Inclusion Criteria
- Moderate mitral regurgitation 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 between 0.2 cmsq to 0.39 cmsq. If ERO < 0.2, 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
- CAD that is amenable to CABG and a clinical indication for revascularization
- Age ≥ 18 years
Exclusion Criteria
- Any evidence of structural (chordal or leaflet) mitral valve disease
- Inability to derive ERO and end-systolic volume index (ESVI) by transthoracic echocardiography
- Planned concomitant intra-operative procedures (with the exception of closure of patent foramen ovale [PFO] or atrial septal defect [ASD]or Maze procedure or left atrial appendage excision)
- Prior surgical or percutaneous mitral valve repair
- Contraindication to cardiopulmonary bypass (CPB)
- Clinical signs of cardiogenic shock at the time of surgery
- Treatment with chronic intravenous inotropic therapy at the time of surgery
- Severe, irreversible pulmonary hypertension in the judgment of the investigator
- 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
- Recent history of psychiatric disease (including drug or alcohol abuse) that is likely to impair compliance with the study, in the judgment of 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 the study
- Any concurrent disease with a life expectancy of less than 2 years
- Pregnancy at the time of randomization
Data sourced from ClinicalTrials.gov (NCT00806988). 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.