Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical Trial

Summary

To establish the safety and effectiveness of the Edwards PASCAL Transcatheter Repair System in patients with symptomatic severe tricuspid regurgitation who have been determined to be at an intermediate or greater estimated risk of mortality with tricuspid valve surgery by the cardiac surgeon with concurrence by the local Heart Team

Conditions

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency
• Tricuspid Valve Disease

Interventions

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in patients on optimal medical therapy

DRUG

Optimal Medical Therapy

Optimal Medical Therapy alone in patients with tricuspid regurgitation

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL System in conjunction with OMT

DEVICE

Edwards PASCAL System

Transcatheter tricuspid valve repair with the Edwards PASCAL system in patients on optimal medical therapy (OMT) with tricuspid regurgitation

Sponsors & Collaborators

• Edwards Lifesciences

  lead INDUSTRY

Principal Investigators

• Martin B. Leon, MD · Columbia University

• Michael J. Mack, MD · Baylor Scott and White Health

• Charles Davidson, MD · Northwestern University

• Allen Anderson, MD · The University of Texas Health Science Center at San Antonio

• Gorav Ailawadi, MD · University of Michigan

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-12-11

Primary Completion

2027-12-31

Completion

2031-12-31

FDA Device

Yes

Countries

• United States
• Canada

Study Locations