Capstan Medical TMVR Study: FIH
ConditionMitral Regurgitation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorCapstan Medical
About this trial
This study is a prospective, multi-center, non-randomized first in human study to evaluate the safety and feasibility of the Capstan Medical TMVR System for intervention in adults with moderate-severe or greater mitral regurgitation who are not surgical candidates.
Eligibility criteria
Qualifiers
Age ≥ 18 years at the time of consent.
Moderate-severe (3+) or severe (4+) mitral regurgitation
NYHA II or greater symptoms despite optimal medical treatment.
The local multi-disciplinary heart team agrees that TMVR is the preferred treatment over surgical intervention or other available treatment options (such as TEER).
Disqualifiers
LVEF less than 20%
Anatomic features (e.g., annular dimensions, neo-LVOT area, transfemoral and transseptal access, excessive MAC) unsuitable for the Capstan System
Severe aortic valve stenosis or regurgitation
Severe mitral stenosis
Trial design
Treatments tested in this trial
- Capstan System transcatheter mitral valve replacement
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov