Safety and Performance of the Cardiovalve TR Replacement System
Not Applicable
Recruiting
- Conditions
- Tricuspid Regurgitation
- Interventions
- Device: Cardiovalve TR valve replacement System
- Registration Number
- NCT05486832
- Lead Sponsor
- Cardiovalve Ltd.
- Brief Summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
- Detailed Description
The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Exclusion Criteria
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cardiovalve TR replacement Group Cardiovalve TR valve replacement System Cardiovalve TR valve replacement System
- Primary Outcome Measures
Name Time Method Freedom from device or procedure-related adverse events 30 days Freedom from device or procedure-related adverse events
Reduction in TR grade 30 days Reduction in TR in comparison to baseline
- Secondary Outcome Measures
Name Time Method Six minute walk test 30 days, 6 months, 12 months, annual for five years Change in Six minute walk distance from Baseline
KCCQ 30 days, 6 months, 12 months, annual for five years Change in health status from Baseline
Trial Locations
- Locations (7)
Universitäres Herz
🇩🇪Hamburg, Germany
Charité university
🇩🇪Berlin, Germany
Universität Bochum
🇩🇪Bad Oeynhausen, Germany
Herzzentrum Uniklinik
🇩🇪Köln, Germany
University Heart Center Lübeck
🇩🇪Lübeck, Germany
Universitätsklinikum - Regensburg
🇩🇪Regensburg, Germany
Uniklinik Bonn
🇩🇪Bonn, Germany