The TRICURE EU Pivotal Study
Recruiting
N/A
Interventional Study
Tricuspid Valve Regurgitation
Heart Valve Disease
Cardiovascular Diseases
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 80 (estimated)
- Sponsor
- TRiCares · Industry
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About This Trial
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* 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 Criteria:
* Patient in need of emergent intervention
* Patient who is hemodynamicall…
Contacts