2019-06 TRISCEND Study

Edwards Lifesciences

Status: Active, not recruiting

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

Treatments: Device: Transcatheter Tricuspid Valve Replacement

Study type: Interventional

Funder types: Industry

Identifiers

NCT04221490

2019-06

Details and patient eligibility

About

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

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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228 participants in 1 patient group

Treatment

Experimental group

Description:

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Treatment:

Device: Transcatheter Tricuspid Valve Replacement