The TRICURE EU Pivotal Study

TRiCares

Status: Enrolling

Conditions: Cardiovascular Diseases; Tricuspid Valve Regurgitation; Heart Valve Disease

Treatments: Device: Transcatheter Tricuspid Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT06581471

2401 (Other Identifier)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

Transcatheter Tricuspid Valve Replacement

Experimental group

Description:

Treatment with the TRiCares Topaz Tricuspid Transcatheter Valve Replacement System

Treatment:

Device: Transcatheter Tricuspid Valve Replacement