Summary

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

Age: 18 Years and older

Gender: All

Start Date: 05/06/2020

Primary Completion Date (Estimated): 01/05/2024

Study Completion Date (Estimated): 01/31/2029

Accepts Healthy Volunteers: No

Trial Purpose and Description

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

Eligibility Criteria

Age: 18 Years and older

Gender: All

Accepts Healthy Volunteers: No

Key inclusion criteria:

* Functional or degenerative TR moderate or greater

* Symptomatic despite medical therapy or prior HF hospitalization from TR

* The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Key exclusion criteria:

* Tricuspid valve anatomic contraindications

* Need for emergent or urgent surgery or any planned cardiac surgery within the next 12 months

* Hemodynamic instability

* Refractory heart failure requiring advanced intervention

* Currently participating in another investigational study in which the patient has not reached a primary endpoint