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Recruiting NCT06506942

The TRICURE EFS Study

No phase Interventional Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

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 Diseases, 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
United States, Canada
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 EFS TRiCares Topaz Transfemoral TRICUspid Heart Valve REplacement System Early Feasibility 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]
  • 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

United States · 8 centers
  • Piedmont Healthcare Inc. — Atlanta
  • Northwestern — Chicago
  • University of Michigan Hospital and Health Systems — Ann Arbor
  • Minneapolis Heart Institute Foundation — Minneapolis
  • Columbia University Medical Center/ NewYork Presbyterian Hospital — New York
  • Montefiore — The Bronx
  • The Christ Hospital — Cincinnati
  • Medical University of South Carolina — Charleston
Canada · 2 centers
  • St. Paul's Hospital — Vancouver
  • St. Michaels Hospital — Toronto

Identifiers

NCT: NCT06506942 · 2301

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗