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Study of CorMatrix Cor TRICUSPID ECM Valve for Surgical Replacement of Tricuspid Valve Disease in Adults and Children
Led by Corvivo Cardiovascular, Inc. · Updated on 2025-09-02
78
Participants Needed
4
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the CorMatrix Cor TRICUSPID ECM Valve, a device designed to replace dysfunctional tricuspid heart valves, in patients needing surgical valve replacement. This pivotal study aims to confirm the devices safe implantation, clinical safety, and performance in treating tricuspid valve disease, including cases secondary to congenital heart disease. The study includes both adult and pediatric patients and is conducted at multiple centers. Participants will undergo tricuspid valve replacement surgery using the CorMatrix ECM Valve. The study includes up to 60 adult and 18 pediatric patients receiving this device. The trial is a single-arm, prospective study focusing on the surgical management of tricuspid valve disease with this valve replacement device. During the study, participants will be followed to assess procedural success at 30 days post-operation, device success at 30 days and subsequent visits, and technical success within 24 hours after implantation. Researchers will monitor safety and performance through clinical evaluations and follow-up visits. The total participation duration extends through the follow-up period to evaluate outcomes after the valve replacement.
CONDITIONS
Brief Title
CorMatrix Cor TRICUSPID ECM Valve Replacement Study
Research Team
R
Robert G Matheny, MD
R
Rhonda B Van Genderen, RN, MBA
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