MitraClip REPAIR MR Study

[...] I/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery pressure systolic pressure > 50 mmHg, or LVESD > 40 mm. Subject is at moderate surgical risk defined as being at least 75 years of age, ORat ifthe time of EC review. If younger than 75 years, then hasthe subject should have: (1) Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR (2) Presence of other comorbidities which may introduce a potential surgery-specific impediment. Subject provides written informed consent. Subject is ≥ 18 years of age. Exclusion Criteria: Subject is currently partic [...] [...]

[...] of at least one interventionalist, and one cardiac surgeon) has confirmed that the subject is a candidate for mitral valve surgery and the EC have confirmed that the patientsubject's mitral valve anatomy is suitable for percutaneous repair [...] re systolic pressure > 50 mmHg, or LVESD > 40 mm. Subject is at moderate surgical risk defined as being at least 75 years of age. If, OR if younger than 75 years, then thehas: subject(1) should have: Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR (2) Presence of other comorbidities which may introduce a potent [...] scie [...]

Proportion of subjects with MR ≤ mild (1+) at 30 days post index procedure among survivors Rate of MV replacement at index procedure Number of days inat hospital afterfrom index procedure to home discharge Proportion of patientssubjects discharged to home post index hospitalization 5Quality pointof life improvement inassessed using the Kansas City Cardiomyopathy Questionnaire (KCCQ) of at least 10 points at 2 years compared to baseline among survivors. Severe symptomatic mitral stenosis at 1 year

SurvivalAll-cause free ofmortality, stroke, and any cardiovascularcardiac hospitalization, or acute kidney injury requiring renal replacement therapy at 2 years (any cardiac hospitalizations in the first 30 days post treatment will be excluded) Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)