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Clinical Trials in the USA / NCT06506942
Recruiting Not applicable

The TRICURE EFS Study

NCT06506942 · tracked via the Priya Life Science USA tracker
Sponsor
TRiCares
Phase
Not applicable
Started
2024-09-11
Last updated
2026-10-29

Condition(s) studied

Tricuspid Valve RegurgitationHeart Valve DiseasesCardiovascular Diseases

Investigational drug(s) / intervention(s)

Transcatheter Tricuspid Valve Replacement

Transcatheter Tricuspid Valve Replacement: Replacement of the tricuspid valve through a transcatheter approach

Study summary

Prospective, multi-center study to assess safety and performance of the TRiCares Topaz Tricuspid Valve Replacement System

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Composite of MAE — 30 day post-intervention
    Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.
  • Device Success — immediately post-intervention
    Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

Trial sites (10)

FacilityCityRegionStatus
Piedmont Healthcare Inc. Atlanta Georgia Recruiting
Northwestern Chicago Illinois Recruiting
University of Michigan Hospital and Health Systems Ann Arbor Michigan Recruiting
Minneapolis Heart Institute Foundation Minneapolis Minnesota Recruiting
Columbia University Medical Center/ NewYork Presbyterian Hospital New York New York Recruiting
Montefiore The Bronx New York Recruiting
The Christ Hospital Cincinnati Ohio Recruiting
Medical University of South Carolina Charleston South Carolina Recruiting
St. Paul's Hospital Vancouver British Columbia Recruiting
St. Michaels Hospital Toronto Ontario Recruiting

More TRiCares trials in the USA

The TRICURE US IDE Pivotal Study Recruiting

Other trials for the same condition

VDyne Transcatheter Tricuspid Valve Replacement Study to Evaluate Safety and Clinical Efficacy in Patients With Symptomatic Severe Tricuspid Valve Regurgitation (TRIVITA Pivotal Trial) Recruiting
Global Paradise System US Post Approval Study Recruiting
TRIFORMIS RESILIA Real-world Study Assessing Safety and Performance (TRIBLAZE Study) Recruiting
RADIANCE Continued Access Protocol Active, not recruiting
A Feasibility Study of the Millipede Transcatheter Annuloplasty Ring System in Patients With Functional Mitral Regurgitation Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06506942 on ClinicalTrials.gov ↗ ← All trials in the USA