Trial Summary
What is the purpose of this trial?The purpose of this study is to assess the safety and performance of Transcatheter Mitral Valve Replacement (TMVR) system for the treatment of severe, symptomatic mitral regurgitation (MR).
Eligibility Criteria
This trial is for individuals at high risk for heart surgery with severe, symptomatic mitral regurgitation and classified as NYHA Class II-IVa. It's not suitable for those with excessive calcification of the mitral valve, severe right ventricular dysfunction, recent stroke or heart attack, or certain other heart conditions.Inclusion Criteria
I have severe leakage in my heart's mitral valve.
My heart condition limits my physical activity.
I am at high risk for heart surgery.
Exclusion Criteria
I have a blockage in the heart affecting blood flow.
I have not had a stroke in the last 90 days.
I have not had a stroke or heart attack in the last 30 days.
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Participant Groups
The study is evaluating a Transcatheter Mitral Valve Replacement (TMVR) system to treat severe mitral regurgitation. The goal is to determine how safe and effective this minimally invasive procedure is in improving heart function.
1Treatment groups
Experimental Treatment
Group I: Transcatheter Mitral Valve ReplacementExperimental Treatment1 Intervention
Patients with symptomatic mitral regurgitation (garde 3 or 4), determined to be a high risk for cardiovascular surgery, will be treated with the Caisson Transcatheter Mitral Valve Replacement (TMVR) System
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Pennsylvania State UniversityHershey, PA
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Who Is Running the Clinical Trial?
Caisson Interventional LLCLead Sponsor