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Edwards CLASP TR EFS | Clinical Trials | Clareo Health

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Edwards CLASP TR EFS

Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

NCT03745313•Edwards Lifesciences

Summary

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Detailed Description

The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Severe functional or degenerative TR
•Symptomatic despite medical therapy
•The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion Criteria

•Unsuitable anatomy
•Previous tricuspid valve repair or replacement
•Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study

Locations (15)

Cedars Sinai Medical Center

Los Angeles, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

St. Vincent Heart Center of Indiana

Indianapolis, Indiana, United States

Henry Ford Hospital

Detroit, Michigan, United States

Mayo Clinic

Rochester, Minnesota, United States

Morristown Medical Center

Morristown, New Jersey, United States

NYU Langone Health

New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital

New York, New York, United States

Cleveland Clinic

Cleveland, Ohio, United States

Key Dates

Start Date

February 5, 2019

Primary Completion Date

May 11, 2021

Completion Date

May 13, 2025

Last Updated

September 29, 2025

Enrollment

ACTUAL participants

Conditions

Tricuspid Regurgitation

Interventions

Edwards PASCAL Transcatheter Valve Repair System

DEVICE

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

NCT07433504

Severe or Greater Tricuspid Regurgitation

View study

RECRUITING

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation

NCT07085650

Atrial Fibrillation (AF)Mitral Regurgitation+1 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 29, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Edwards CLASP TR EFS

Inclusion Criteria

Exclusion Criteria

A Prospective, Multicenter, Randomized Controlled Clinical Trial of Transcatheter Tricuspid Valve Clipping Systems.

The Multi-center Study of Comprehensive Atrial Fibrillation Regurgitation and Recurrent Events Evaluation

TRIcvalve biCAVal Valve System for Severe Tricuspid Regurgitation (TRICAV-I)

Pacemaker-related Tricuspid Regurgitation Progression and Long-term Outcomes

Tricuspid RegUrgitaTion Hamburg Cohort

German Registry for Transcatheter Tricuspid Valve Interventions