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Not yet recruiting NCT07528326

The TRICURE US IDE Pivotal Study

No phase Interventional Tricuspid Regurgitation (TR)

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: TRiCares Topaz TTVR System, Edwards EVOQUE TTVR System, TRiCares Topaz TTVR System.
Who it may be relevant to
Registry conditions: Tricuspid Regurgitation (TR). 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
Center list to be confirmed — check the primary protocol.
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

TRiCares Topaz Transcatheter Tricuspid Heart Valve Replacement System IDE Pivotal Study

Overview

The purpose of the study is to evaluate safety and effectiveness of the TRiCares Topaz TTVR system for treatment of subjects presenting with clinically relevant tricuspid regurgitation who are suitable for valve replacement.

Detailed description

The TRICURE US IDE Pivotal Study is a prospective, global, multi-center, randomized (1:1) controlled study (RCT) designed to evaluate the safety and effectiveness of the TRiCares Topaz TTVR System compared to the Edwards EVOQUE TTVR System in subjects with severe or greater tricuspid regurgitation.

Interventions

  • Device TRiCares Topaz TTVR System
    TRiCares Topaz TTVR System
  • Device Edwards EVOQUE TTVR System
    Edwards EVOQUE TTVR System
  • Device TRiCares Topaz TTVR System
    TRiCares Topaz TTVR System

Primary outcome measures

  • Rate of Major Adverse Events (MAE) [Time frame: 30 days post-procedure]
  • Composite Endpoint [Time frame: 1 year post-procedure]
Secondary outcome measures (1)
  • Change in qualify of life (QoL) [Time frame: 1 year post-procedure]

Eligibility criteria

Inclusion criteria

  • Patient is ≥ 18 years of age
  • Patient has severe or greater tricuspid regurgitation with symptoms despite optimal medical therapy
  • Patient is an appropriate candidate to undergo TTVR as determined by the Institution Heart Team

Exclusion criteria

  • Patient has a tricuspid device currently in place
  • Patient has anatomical contraindications
  • Patient is in need of urgent surgery
  • Patient has a left ventricular ejection fraction of < 25%
  • Patient has life expectancy of < 1 year

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07528326 · 2501

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗