The TRICURE EFS Study
- Conditions
- Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular DiseasesTricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases
- Interventions
- Device: Transcatheter Tricuspid Valve Replacement
- Registration Number
- NCT06506942
- Lead Sponsor
- TRiCares
- Brief Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
- Detailed Description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 10
- Adult patients
- Tricuspid regurgitation grade 3 (severe) on a scale of 0 (none) to 5 (torrential)
- Institutional Heart Team evaluates patient as being at increased operative risk
- Patient in need of emergent intervention
- Patient who is hemodynamically unstable
- Anatomical contraindications for implantation with study device
- Patient who is currently participating in another clinical investigation where the primary endpoint was not reached yet
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Transcatheter Tricuspid Valve Replacement Transcatheter Tricuspid Valve Replacement Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System
- Primary Outcome Measures
Name Time Method Device Success immediately post-intervention Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
Composite of MAE 30 day post-intervention Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Composite of MAE 30 day post-intervention Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
Device Success immediately post-intervention Device success defined as a reduction in tricuspid regurgitation immediately post-intervention
- Secondary Outcome Measures
Name Time Method New York Heart Association (NYHA) Function Class 30 days, 6 months, annual for five years post-intervention Number of patients presenting with improvement in NYHA classification
Reduction in Tricuspid Regurgitation (TR) Grade 30 days, 6 months, annual for five years post-intervention Number of patients presenting with reduction in TR grade compared to baseline assessment
Six minute walk test 30 days, 6 months, annual for five years post-intervention Change in distance (m) compared to baseline assessment
Six minute walk test 30 days, 6 months, annual for five years post-intervention Change in distance (m) compared to baseline assessment
Reduction in Tricuspid Regurgitation (TR) Grade 30 days, 6 months, annual for five years post-intervention Number of patients presenting with reduction in TR grade compared to baseline assessment
New York Heart Association (NYHA) Function Class 30 days, 6 months, annual for five years post-intervention Number of patients presenting with improvement in NYHA classification
Trial Locations
- Locations (12)
Piedmont Healthcare Inc.
🇺🇸Atlanta, Georgia, United States
University of Michigan Hospital and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
🇺🇸New York, New York, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Piedmont Healthcare Inc.
🇺🇸Atlanta, Georgia, United States
Northwestern
🇺🇸Chicago, Illinois, United States
University of Michigan Hospital and Health Systems
🇺🇸Ann Arbor, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Montefiore
🇺🇸Bronx, New York, United States
Columbia University Medical Center/ NewYork Presbyterian Hospital
🇺🇸New York, New York, United States
The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States