The TRICURE First in Human Trial

TRiCares

Status

Active, not recruiting

Conditions

Tricuspid Regurgitation

Treatments

Device: Topaz TTVR System

Study type

Interventional

Funder types

Industry

Identifiers

NCT05126030

2101

Details and patient eligibility

About

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.

Full description

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

Enrollment

20 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No 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.