MitraClip REPAIR MR Study (NCT04198870) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
MitraClip REPAIR MR Study
United States500 participantsStarted 2020-07-21
Plain-language summary
The objective of this randomized controlled trial (RCT) is to compare the clinical outcome of MitraClipâ„¢ device versus surgical repair in patients with severe primary MR who are at moderate surgical risk and whose mitral valve has been determined to be suitable for correction by MV repair surgery by the cardiac surgeon on the local site heart team.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has severe (Grade III or greater per the ASE criteria, which includes severity grades of 3+ and 4+) primary MR (mixed etiology is acceptable provided the principal mechanism of action is a degenerative mitral valve) as assessed by the ECL.
✓. The cardiac surgeon of the Site Heart Team (consisting 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 subject's mitral valve anatomy is suitable for percutaneous repair with the MitraClip™ device with high certainty of achieving MR ≤ mild
✓. Subject is symptomatic (NYHA Class II/III/IV) or asymptomatic with LVEF ≤ 60%, pulmonary artery systolic pressure \> 50 mmHg, or LVESD \> 40 mm
✓. Subject is at moderate surgical risk defined as being at least 75 years of age at the time of EC review. If younger than 75 years, then the subject should have:
✓. Society of Thoracic Surgeons (STS) Predicted Risk of Mortality (PROM) Repair Score ≥ 2%, OR
✓. 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 participating in another clinical investigation
✕. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
What they're measuring
1
All-cause mortality, stroke, cardiac 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)
Timeframe: 2 Years
2
Proportion of subjects with moderate or less MR (≤2+), without mitral valve replacement, and without recurrent mitral valve intervention (surgical or percutaneous)