Anchord Mitral Chordal Repair System - FIH
ConditionMitral Regurgitation
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorLifecord Otd
About this trial
The goal of this clinical trial is to generate initial human clinical experience and evaluate procedural feasibility, device deployment, and early safety under controlled First-In-Human conditions for the Anchord Mitral Chordal Repair System in patients with degenerative mitral regurgitation. The main question\[s\] it aims to answer are to assess the safety of procedure, the reduction in mitral regurgitation severity and changes in hemodynamic and symptomatic status.
Participants will be implanted with the Anchord device.
Eligibility criteria
Qualifiers
Severe symptomatic degenerative mitral regurgitation (grade 3+)
High surgical risk for open-heart mitral valve repair or replacement
Suitable anatomy for transcatheter chordal repair as determined by the treating physician
Ability to undergo required echocardiographic and fluoroscopic imaging
Disqualifiers
Active endocarditis or systemic infection
Severe left ventricular dysfunction (LVEF <30%)
Significant non-mitral valvular disease requiring intervention
Severe mitral annular calcification (MAC)
Trial design
Treatments tested in this trial
- Anchord device implantation
Treatment groups
5 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov