Status:
RECRUITING
"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System
Lead Sponsor:
Cardiovalve Ltd.
Conditions:
Tricuspid Regurgitation
Eligibility:
All Genders
18-85 years
Phase:
NA
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
Eligibility Criteria
Inclusion
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Exclusion
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
Key Trial Info
Start Date :
December 9 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2033
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT05486832
Start Date
December 9 2022
End Date
December 15 2033
Last Update
January 5 2026
Active Locations (7)
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1
Universität Bochum
Bad Oeynhausen, Germany, 32545
2
Charité university
Berlin, Germany, 10117
3
Uniklinik Bonn
Bonn, Germany, 53127
4
Herzzentrum Uniklinik
Cologne, Germany, 50937