RecruitingNot ApplicableNCT06581471
The TRICURE EU Pivotal Study
The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
Sponsor
TRiCares
Enrollment
80 participants
Start Date
Aug 29, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Eligibility
Min Age: 18 Years
Inclusion Criteria3
- 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
Exclusion Criteria4
- 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
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Interventions
DEVICETranscatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Locations(8)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06581471
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