RecruitingNot ApplicableNCT05486832
"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System
"TARGET Study": Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation
Sponsor
Cardiovalve Ltd.
Enrollment
100 participants
Start Date
Dec 9, 2022
Study Type
INTERVENTIONAL
Conditions
Summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Eligibility
Min Age: 18 YearsMax Age: 85 Years
Inclusion Criteria3
- Functional TR ≥3+
- Symptomatic, NYHA Class II-IVa
- Patient approved by the Subject Screening Committee
Exclusion Criteria4
- Cardiac anatomy deemed not suitable for the Cardiovalve TR system
- Hemodynamic instability
- Severe right ventricular failure
- Refractory heart failure requiring advanced intervention
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Interventions
DEVICECardiovalve TR valve replacement System
The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Locations(7)
View Full Details on ClinicalTrials.gov
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NCT05486832
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