TRiCares Topaz for Severe Tricuspid Regurgitation
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
Who this trial is looking for
This trial is looking for adults with severe tricuspid regurgitation. Participants will evaluate a device designed to help with their heart condition and assess its safety and performance.
Are You a Good Fit for This Trial?
You may be able to join if
- I am an adult
- I have severe tricuspid regurgitation (grade 3)
- My Heart Team thinks I am at increased operative risk
You may not be able to join if
- I need emergency surgery
- I am hemodynamically unstable
- I have anatomical issues that prevent me from using the study device
- I am taking part in another clinical trial that isn’t finished yet
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Check Your Eligibility
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