Objectives To evaluate the safety and efficacy of mitral valve repair for moderate ischemic mitral regurgitation
Study Design Randomized multi-center trial
Target Population Patients diagnosed with moderate ischemic MR with a clinical indication for CABG
Rx Arms 300 subjects; 90% power to detect an absolute difference of 12 ml/m2 in LVESVI (based on a 20% (repair) v. 5% (CABG alone) reduction in LVESVI)
Sample Size 300 subjects; 90% power to detect an absolute difference of 12 ml/m2 in LVESVI (based on a 20% (repair) v. 5% (CABG alone) reduction in LVESVI)
Duration 24 months following randomization
Primary Degree Endpoints Degree of left ventricular remodeling, as assessed by Left Ventricular End Systolic Volume Index (LVESVI) at 12 months
Secondary Degree Endpoints
  • MACE (death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, mitral valve [MV] re-intervention); (Principal secondary endpoint)
  • All-cause mortality
  • NYHA Classification and CCSC Angina class
  • Peak VO2 (assessed by cardio-pulmonary stress test)
  • LOS for the index hospitalization and discharge location
  • Readmission rates & days alive out of hospital
  • Echo parameters
  • Adequacy of revascularization
  • Change in quality of life (QOL)
  • Neurocognitive outcomes
  • Cost and cost effectiveness
  • Incidence of serious adverse events
  • Re-operation for MR and freedom from re-operation in general
Selected Inclusion Criteria
  • Moderate mitral regurgitation (ERO "e 0.2 and < 0.4 cm2)
  • Coronary artery disease amenable to coronary artery bypass grafting and a clinical indication for revascularization
Selected Exclusion Criteria
  • Any evidence of structural (chordal or leaflet) mitral valve disease
  • Inability to derive ERO and ESVI by transthoracic echocardiography
  • Planned concomitant intra-operative procedures (except closure of PFO or ASD)
  • Planned concomitant intra-operative Maze procedure
  • Prior cardiac surgery
  • Prior percutaneous mitral valve repair
  • Contraindication to cardiopulmonary bypass (CPB)
  • Clinical signs of cardiogenic shock at the time of randomization
  • Treatment with chronic intravenous inotropic therapy at the time of randomization
  • Severe pulmonary hypertension (PAS "e 60 mmHg)
  • ST segment elevation MI requiring intervention within 7 days prior to randomization
  • Congenital heart disease (except PFO or ASD)
  • Chronic renal insufficiency defined by Cr "e 2.5 or chronic renal replacement Rx
  • Evidence of cirrhosis or hepatic synthetic failure


Objectives To evaluate the safety and efficacy of mitral valve repair and mitral valve replacement for patients with severe ischemic mitral regurgitation (MR)
Study Design Randomized multi-center trial
Target Population Patients diagnosed with severe ischemic MR in need of surgical intervention
Rx Arms (a) mitral valve repair with annuloplasty and a sub-valvular procedure for severe tethering (b) mitral valve replacement and complete preservation of the sub-valvular apparatus
Sample Size 250 subjects; 90% power to detect an absolute difference of 15 ml/m2 in LVESVI (based on a 35% (replacement) v. 20% (repair) reduction in LVESVI)
Duration 24 months following randomization
Primary Degree Endpoints Degree of left ventricular remodeling, as assessed by Left Ventricular End Systolic Volume Index (LVESVI) at 12 months
Secondary Degree Endpoints
  • All-cause mortality (Principal secondary endpoint)
  • Operative time, cardiopulmonary bypass (CPB) and cross clamp time
  • Blood loss and transfusion
  • MACE (death, stroke, worsening heart failure (+1 NYHA Class), CHF hospitalization, mitral valve re-intervention)
  • NYHA Classification and CCSC Angina class
  • Peak VO2 (assessed by cardio-pulmonary stress test)
  • LOS for the index hospitalization and discharge location
  • Re-admission rates and days alive out of hospital
  • Echo parameters
  • Adequacy of revascularization
  • Change in quality of life (QOL)
  • Neurocognitive outcomes
  • Cost and cost effectiveness
  • Incidence of serious adverse events
  • Re-operation for MR and freedom from re-operation in general
Selected Inclusion Criteria
  • Chronic severe ischemic mitral regurgitation (ERO "e 0.4 cm2) with tethering
  • Eligible for surgical repair and replacement of mitral valve
  • Coronary artery disease with or without the need for coronary revascularization
Selected Exclustion Criteria
  • Any evidence of structural mitral valve disease or ruptured papillary muscle
  • Lack of mitral valve tethering
  • Prior mitral valve repair
  • Severe pulmonary hypertension or severe RV dysfunction
  • Contraindications to CPB
  • Inability to derive ERO and ESVI by transthoracic echocardiography
  • Planned concomitant intra-operative procedures (except closure of PFO or ASD)
  • Clinical signs of cardiogenic shock at the time of randomization
  • Treatment with chronic intravenous inotropic therapy at the time of randomization
  • ST segment elevation MI requiring intervention within 7 days prior to randomization
  • Congenital heart disease (except PFO or ASD)
  • Chronic renal insufficiency defined by Cr "e 2.5 or chronic renal replacement Rx
  • Evidence of cirrhosis or hepatic synthetic failure


Objectives
  • To compare the effect of MVS alone or in combination with AF ablation on postop heart rhythm in patients with MV disease and non-paroxysmal AF
  • Compare effectiveness of PVI vs. biatrial lesion set for ablating AF in patients undergoing MVS
  • Compare 2 different techniques for post-ablation heart rhythm monitoring (long-term monitor at 12 months vs. weekly rhythm strips) to guide follow-up strategies for future studies of rhythm control in AF patients
  • Compare quality of life in non-paroxysmal AF patients who undergo surgery for mitral valve disease and receive surgical AF ablation to those who receive MVS alone
Study Design Randomized Control Trial; patients randomized with equal allocation to MVS alone or to MVS + AF ablation; patients randomized to MVS + ablation further randomized (1:1) to PVI or ablation with biatrial lesion set.
Target Population Adult patients with non-paroxysmal AF who are undergoing MVS.
Rx Arms MVS alone versus MVS + AF abalation
Sample Size 260 patients; provides 90% power to detect a 20% difference in freedom from AF at one-year (25% versus 45%)
Primary Degree Endpoints Freedom from AF at 1-year in patients with mitral valve disease and non-paroxysmal AF. The primary efficacy endpoint will be assessed with 3-day continuous monitoring at 12 months post-ablation.
Secondary Degree Endpoints AF load; survival; MACE; NYHA class; QoL; cost; safety
Inclusion Criteria Age ≥18; primary MVS; may include need for surgical management of functional tricuspid regurgitation or patent foramen ovale; may include sternotomy or minimally invasive procedure; Non-paroxysmal AF for "e3 months; Willing and able to use heart rhythm monitor
Exclusion Criteria AF is paroxysmal; AF w/o indication for cardiac surgery; functional MR; active infx; patient does not understand nature, significance and scope of study; previous heart surgery; surgical management of hypertrophic obstructive cardiomyopathy, ascending aorta or aortic arch pathology, coronary artery disease, aortic valve disease