Edwards CLASP TR EFS

Tricuspid Regurgitation Clinical Trial

— CLASP TR EFS  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03745313
• Other study ID #: 2018-10
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 5, 2019
• Est. completion date: May 31, 2026

Study information

• Verified date: March 2023
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 65
• Est. completion date: May 31, 2026
• Est. primary completion date: May 11, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Tricuspid Regurgitation
• Tricuspid Valve Insufficiency

Intervention

Device:
• Edwards PASCAL Transcatheter Valve Repair System
Repair of the tricuspid valve through a transcatheter approach

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Northwestern University	Chicago	Illinois
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Hospital	Detroit	Michigan
United States	St. Vincent Heart Center of Indiana	Indianapolis	Indiana
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Morristown Medical Center	Morristown	New Jersey
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Medical Center/New York Presbyterian Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure-related adverse events	Safety assessed by freedom from device or procedure-related adverse events	30 days
Secondary	NYHA Functional Class	Number of patients with improvement in NYHA class	30 days, 6 Months, 12 Months, annual for five years
Secondary	Six minute walk test	Change in distance (m) from baseline	30 days , 6 months, 1 year
Secondary	Reduction in TR grade	Number of patients with reduction in TR from baseline	30 days, 3 Months ,6 Months, 12 Months, annual for five years
Secondary	Health Status - KCCQ	Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire	30 days, 6 months, 1 year
Secondary	Health Status - SF-36	Number of points of improvement in health status as measured by 36 item short form survey (SF-36)	30 days, 6 months, 1 year