The Half Moon Transcatheter Mitral Valve Repair (TMVr) Pilot Study
ConditionMitral Valve Insufficiency
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-95
SponsorHalf Moon Medical
About this trial
The study is a prospective, multi-center, single-arm, non-randomized, Early Feasibility Study (EFS) to evaluate the safety and performance of the Half Moon TMVr System in patients with severe, symptomatic mitral regurgitation, who are at high risk for conventional mitral valve surgery.
Eligibility criteria
Qualifiers
Moderately severe or severe mitral regurgitation (MR Grade ≥ 3+)
Symptomatic mitral regurgitation (NYHA Class II-IV), despite guideline-directed medical therapy (GDMT) determined by the local multidisciplinary heart team
Deemed, by the local multidisciplinary heart team, to be at high risk for mitral valve surgery and not appropriate for commercially approved transcatheter mitral valve therapies
Age ≥ 21
Disqualifiers
Prior transseptal intervention with occlusion device currently implanted
Implanted with venous stents (iliac and femoral) including inferior vena cava (IVC) filter or congenital abnormalities of the IVC that would preclude ability for transfemoral access with the delivery system
Evidence of intracardiac, inferior vena cava, or femoral venous mass, thrombus, or vegetation
Prohibitive mitral annular or leaflet calcification
Trial design
Treatments tested in this trial
- Half Moon TMVr System
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov