The TRICURE EU Pivotal Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transcatheter Tricuspid Valve Replacement.
- Who it may be relevant to
- Registry conditions: Tricuspid Valve Regurgitation, Heart Valve Disease, Cardiovascular Diseases. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Belgium, Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The TRICURE EU PIVOTAL TRiCares Topaz Transcatheter TRICUspid Heart Valve REplacement System EUropean PIVOTAL Study
Overview
Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System
Detailed description
The study is a multi-center, prospective single arm study designed to evaluate the safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System.
Interventions
- Device Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Primary outcome measures
- Composite of MAE [Time frame: 30 day post-intervention]
- Investigational Device Success [Time frame: immediately post-intervention]
Secondary outcome measures (3)
- Six minute walk test [Time frame: 30 days, 6 months, annual for five years post-intervention]
- Reduction in Tricuspid Regurgitation (TR) Grade [Time frame: 30 days, 6 months, annual for five years post-intervention]
- New York Heart Association (NYHA) Function Class [Time frame: 30 days, 6 months, annual for five years post-intervention]
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 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Belgium · 6 centers
- Algemeen Stedelijk Ziekenhuis — Aalst
- ZNA Middelheim — Antwerp
- UZ Brussel — Brussels
- Cliniques Universitaires Saint-Luc UCL — Brussels
- Centre hospitalier universitaire CHU de Liège — Liège
- AZ Delta — Roeselare
Germany · 2 centers
- University Medical Center of the Johannes Gutenberg University Mainz — Mainz
- Ludwig Maximilian University Hospital — Munich
Identifiers
NCT: NCT06581471 · 2401