TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System

TARGET Study: Safety and Performance of the Cardiovalve TR Replacement System for Tricuspid Regurgitation

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

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

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