No phaseNot yet recruiting
A Prospective, Randomized Multicenter Clinical Trial of the TricValve® Transcatheter Bicaval Valve System in Subjects With Severe Tricuspid Regurgitation. (TRICAV-II)
- Sponsor
- P+F Products + Features USA Inc. (Industry)
- Enrolment
- 780 planned
- Conditions
- Tricuspid Valve Disease; Heart Valve Diseases; Cardiovascular Diseases; Heart Failure; Tricuspid Valve Regurgitation; Tricuspid Valve Insufficiency
- Interventions
- TricValve System; Optimal medical therapy
- Ages
- adults, older adults
- Registry
- NCT06458907
Full record on ClinicalTrials.gov
From the registry
Pivotal trial to evaluate the safety and effectiveness of the P\&F TricValve® Transcatheter Bicaval Valve System.
Primary outcomes
- Randomized Cohort: Caval Reflux (CR) grade reduction
- Randomized Cohort: Hierarchical composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement
- Randomized Cohort: Rate of Major Adverse Events (MAE)
- Randomized Cohort: Hierarchical composite endpoint: all-cause mortality, RVAD implantation or heart transplant, tricuspid valve surgery or percutaneous tricuspid intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improv
History
Study completion expected
Primary completion expected
Expected to start
Last registry update
Registered