Safety and Performance of the Cardiovalve TR Replacement System (TARGET)

Cardiovalve

Status: Enrolling

Conditions: Tricuspid Regurgitation

Treatments: Device: Cardiovalve TR valve replacement System

Study type: Interventional

Funder types: Industry

Identifiers

NCT05486832

CP-21-01

Details and patient eligibility

About

The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

Full description

The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Functional TR ≥3+
• Symptomatic, NYHA Class II-IVa
• Patient approved by the Subject Screening Committee

Exclusion criteria

• Cardiac anatomy deemed not suitable for the Cardiovalve TR system
• Hemodynamic instability
• Severe right ventricular failure
• Refractory heart failure requiring advanced intervention

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Cardiovalve TR replacement Group

Experimental group

Description:

Cardiovalve TR valve replacement System

Treatment:

Device: Cardiovalve TR valve replacement System