Actively Recruiting
Observing Outcomes of Abbott TriClip17 Device for Treating Severe Tricuspid Regurgitation and Right Heart Failure in Adults
Led by Helios Klinikum Pforzheim · Updated on 2023-09-22
200
Participants Needed
1
Research Sites
52 weeks
Total Duration
AI-Summary
What this Trial Is About
Significant tricuspid regurgitation TR is common in elderly patients and often leads to right heart failure RHF with limited treatment options. Surgical intervention carries high risk due to factors like advanced age and organ dysfunction. This observational study aims to assess the safety and performance of the TriClip device, a percutaneous treatment designed specifically for TR, in critically ill patients at high or prohibitive surgical risk. Participants will receive a percutaneous edge-to-edge repair of the tricuspid valve using the TriClip system. This single-arm, open-label, prospective registry evaluates real-world outcomes in patients with symptomatic severe TR despite medical therapy. The study follows patients over time to monitor procedural success and clinical benefits of the TriClip device. During the study, participants will be monitored at 12 months for procedural success, changes in quality of life, functional capacity, and major organ system function. The trial collects data on safety and effectiveness in a real-world setting, helping to understand how TriClip therapy impacts patients with right heart failure and tricuspid valve disease over the short and longer term.
CONDITIONS
Brief Title
Pforzheim Tricuspid Valve Registry - Outcomes of Percutaneous Tricuspid Valve Repair
Research Team
I
Ilka Ott, MD, PhD
A
Alexandru Patrascu, MD
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