TRISCEND II Pivotal Trial

Edwards Lifesciences

Status: Enrolling

Conditions: Heart Valve Diseases; Tricuspid Valve Insufficiency; Cardiovascular Diseases; Heart Failure; Tricuspid Valve Disease; Tricuspid Valve Regurgitation

Treatments: Device: Edwards EVOQUE System; Drug: Optimal Medical Therapy

Study type: Interventional

Funder types: Industry

Identifiers

NCT04482062

2020-05

Details and patient eligibility

About

Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Full description

The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Enrollment: 1,070 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Symptomatic tricuspid regurgitation (TR) despite medical therapy
• TR graded as severe or greater
• Appropriate for transcatheter tricuspid valve replacement per the local heart team

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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1,070 participants in 4 patient groups

Edwards EVOQUE System & OMT

Experimental group

Description:

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation

Treatment:

Device: Edwards EVOQUE System

Optimal Medical Therapy (OMT)

Active Comparator group

Description:

Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation

Treatment:

Drug: Optimal Medical Therapy

Single-Arm Registry

Experimental group

Description:

Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization

Treatment:

Device: Edwards EVOQUE System

Continued Access Study

Experimental group

Description:

Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.

Treatment:

Device: Edwards EVOQUE System