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NCT07671820
Anchord Mitral Chordal Repair System - FIH
Conditions: Mitral Regurgitation
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 5
Sponsor: Lifecord Otd
Summary
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
Inclusion Criteria:
* 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
* Ability to provide informed consent
Exclusion Criteria:
* Active endocarditis or systemic infection
* Severe left ventricular dysfunction (LVEF \
Source: ClinicalTrials.gov (NCT07671820). StuddyBuddy aggregates publicly available trial information.