The Pforzheim Tricuspid Valve Registry study is designed to confirm the safety and performance of the TriClip™ device in a contemporary real-world setting in critically ill patients. The observational trial is a prospective, single arm, open-label, single-center, post market registry.
Subjects (>=18 years age) have severe tricuspid regurgitation and are symptomatic despite medical therapy.
Subjects eligible to receive the TriClip™
Subjects must provide written informed consent prior to study procedure.
Subjects participating in another clinical study that may impact the follow-up or results of this study.
All subjects who have symptomatic severe tricuspid regurgitation despite medical therapy and are eligible to receive the TriClip™
Cohort
Prospective
Transcatheter edge-to-edge tricuspid valve repair
Procedure/SurgeryPercutaneous edge to edge repair of tricuspid valve using the TriClip system
Procedural Success
One-grade reduction of tricuspid regurgitation
Change in quality of life
NYHA class
Change in functional capacity
6-minute walk test
Major organ system functional change
Renal and hepatic function as assessed by following lab values: creatinine, glomerular filtration rate, aspartate transaminase, alanine aminotransferase and bilirubine
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