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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
5
Anchord Mitral Chordal Repair device implantation
Incidence of device or procedure related major adverse events [Safety]
Freedom from device- or procedure-related major adverse events.
Time frame: 30 days post-procedure.
Number of Successful device implantation assessed by imaging [Technical Success]
Successful delivery, deployment, and secure fixation of the device assessed during the procedure.
Time frame: Day 0 - Procedure day
MR reduction
Mitral regurgitation reduction of 1 or more degrees
Time frame: 30 days
NYHA class
Improvement in NYHA functional by 1 or more degrees
Time frame: 90 days post procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.