Actively Recruiting
Safety and Feasibility of Laplace Transcatheter Tricuspid Valve Replacement System Using Minimally Invasive Valve Replacement for Severe Tricuspid Regurgitation
Led by Laplace Interventional, Inc · Updated on 2026-07-23
65
Participants Needed
10
Research Sites
261 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and technical feasibility of the Laplace Transcatheter Tricuspid Valve Replacement TTVR System in patients with severe, symptomatic tricuspid regurgitation. This early feasibility, prospective, single-arm, multi-center study aims to assess how well the Laplace TTVR System performs as a minimally invasive treatment option for this condition. Participants will undergo transcatheter replacement of their native tricuspid valve using the Laplace bioprosthesis. This device is delivered via either trans-jugular or transfemoral access, replacing the damaged valve through a minimally invasive procedure. The study focuses on the technical success during the procedure and the devices performance up to 30 days after implantation. During the study, participants will be closely monitored through follow-up visits to assess procedural and device success as well as safety. Evaluations include echocardiograms and clinical assessments to measure outcomes related to the valve replacement. Participants must agree to attend all required post-procedure visits, and the study is planned to continue until December 2032, with primary completion expected by December 2027.
CONDITIONS
Brief Title
Early Feasibility Study (EFS) Laplace Transcatheter Tricuspid Valve Replacement (TTVR) System
Research Team
R
Ryan Gladney
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