Study of the TricValve Transcatheter Bicaval Valve System for Treating Severe Tricuspid Regurgitation in Adults at High Surgical Risk

What this Trial Is About

Researchers are evaluating the TricValve Transcatheter Bicaval Valve System in people with severe tricuspid regurgitation who are considered high risk for surgery. This prospective multicenter study aims to assess the safety and effectiveness of this system in improving outcomes for symptomatic adults. The study is sponsored by PF Products Features USA Inc. and participants will be followed closely after treatment to gather long-term data for up to five years. The TricValve System includes two valves designed for placement in the superior and inferior vena cava without affecting the native tricuspid valve. These valves are made from bovine pericardium leaflets on a nitinol stent and are delivered percutaneously through the transfemoral approach. Participants will receive the TricValve implantation and continue to be managed with optimal medical therapy as directed by their physician. After the procedure, patients will be monitored closely for one year with ongoing annual assessments. During the study, patients will undergo evaluations to monitor mortality, stroke, pulmonary embolism, bleeding complications, kidney injury, and device-related events within specified timeframes. Researchers will also assess heart function, quality of life using the Kansas City Cardiomyopathy Questionnaire, and physical capacity through the Six Minute Walking Test over 12 months. Safety and efficacy data will be collected regularly, including technical success of device placement and heart failure events. Participants will be followed yearly for up to five years to observe long-term outcomes.

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)