The TRICURE First in Human Trial

TRiCares Topaz Transfemoral Tricuspid Heart Valve Replacement System First in Human Trial

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05126030

Acronym

TRICURE

Enrollment

Registered

2021-11-18

Start date

2022-07-15

Completion date

2029-05-15

Last updated

2025-03-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tricuspid Regurgitation

Brief summary

The objective of this first in human study is to gain early clinical insight into the safety profile and performance of the Topaz transcatheter tricuspid valve replacement (TTVR) system intended for transfemoral access to deliver a self-expanding bioprosthetic valve within the tricuspid valve.

Detailed description

The TRiCares Topaz Prosthesis is intended to replace a diseased tricuspid heart valve via a transcatheter approach without removing the native valve.

Interventions

DEVICETopaz TTVR System

Transcatheter tricuspid heart valve replacement

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

Topaz TTVR System

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Subject of age \>18 years. * Subject with severe symptomatic tricuspid regurgitation presenting following conditions: 1. TR severity of at least 3 (severe) on a scale of 0 (none) to 5 (torrential), assessed by independent core lab and/or 2. symptoms requiring use of diuretics. * Subject presenting with New York Heart Association Class NYHA ≥II. * Subject is not eligible for open tricuspid valve surgery due to high operative risk, as determined by a Heart Team decision.

Exclusion criteria

* Subject in need of emergent or urgent intervention or any planned cardiac intervention within the next 12 months. * Subject undergoing cardiac interventions within 30 days prior to index procedure. * Subject with concomitant clinically relevant mitral, aortic, pulmonary regurgitation/stenosis. * Subject who had previous tricuspid valve replacement or repair and a device is still in situ.

Design outcomes

Primary

Measure	Time frame	Description
Hierarchical composite endpoint	30 days	including all-cause mortality, re-hospitalization for heart failure, re-intervention for failed tricuspid intervention, and KCCQ worsening at 30 days

Countries

Belgium, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026