Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

Early Feasibility Study of the Edwards FORMA Tricuspid Transcatheter Repair System

The study is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

The early feasibility study of the Edwards FORMA Tricuspid Transcatheter Repair System is a multi-center, prospective, early feasibility study to measure individual patient clinical outcomes and effectiveness, evaluate the safety and function, provide guidance for future clinical study designs and development efforts of the Edwards FORMA Tricuspid Transcatheter Repair System.

Data collected in this clinical study will include safety and function of the investigational system as well as up to 3 year clinical outcomes.

Inclusion Criteria:

1. ≥ 18 years old
2. Clinically significant, symptomatic, functional, tricuspid regurgitation (per applicable guidelines) requiring transcatheter tricuspid valve repair as assessed by the local Heart Team

Exclusion Criteria:

1. Tricuspid valve/right heart anatomy not suitable for the study device
2. Moderate or greater tricuspid valve stenosis
3. Severe RV dysfunction