BridgeMD
New treatment option for Tricuspid Valve Regurgitation
Official title The TRICURE EU Pivotal Study
ClinicalTrials.gov ID: NCT06581471
What this study is testing
- What it's testing
- Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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
You likely can't join if
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Aalst, Belgium
- Antwerp, Belgium
- Brussels, Belgium
- Liège, Belgium
- Roeselare, Belgium
- Mainz, Germany
- Munich, Germany
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Aalst, Belgium; Antwerp, Belgium; Brussels, Belgium; Liège, Belgium; Roeselare, Belgium; Mainz, Germany and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.