Cardiovalve TR valve replacement System: The Cardiovalve system includes a valve and delivery system, designed for replacement of the tricuspid valve through a transcatheter.
Study summary
The objective of this study is to evaluate the safety and performance of Cardiovalve TR system
Eligibility
Sex
ALL
Min age
18 Years
Max age
85 Years
Healthy volunteers
No
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
Primary outcome measure(s)
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
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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