The TRICURE EFS Study

TRiCares15 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases

Interventions

Transcatheter Tricuspid Valve ReplacementDEVICE

Replacement of the tricuspid valve through a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (8)

Piedmont Healthcare Inc.

Atlanta, Georgia, United States

RECRUITING

Northwestern

Chicago, Illinois, United States

NOT_YET_RECRUITING

University of Michigan Hospital and Health Systems

Ann Arbor, Michigan, United States

Outcomes

Primary Outcomes

Composite of MAE

Composite rate of major adverse events (MAEs) at 30 days, including mortality, myocardial infarction, stroke and major complications.

Time frame: 30 day post-intervention

Device Success

Device success defined as a reduction in tricuspid regurgitation immediately post-intervention

Time frame: immediately post-intervention

Secondary Outcomes

Six minute walk test

Change in distance (m) compared to baseline assessment

Time frame: 30 days, 6 months, annual for five years post-intervention

Reduction in Tricuspid Regurgitation (TR) Grade

Number of patients presenting with reduction in TR grade compared to baseline assessment

Time frame: 30 days, 6 months, annual for five years post-intervention

New York Heart Association (NYHA) Function Class

Number of patients presenting with improvement in NYHA classification

Time frame: 30 days, 6 months, annual for five years post-intervention

Central Contacts

Esther Gerteis

CONTACT

+41796015318 gerteis@tricares.de

Data from ClinicalTrials.gov

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