2019-06 TRISCEND Study

Cardiovascular Diseases Clinical Trial

Official title:

Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04221490
• Other study ID #: 2019-06
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 6, 2020
• Est. completion date: January 31, 2029

Study information

• Verified date: March 2024
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 228
• Est. completion date: January 31, 2029
• Est. primary completion date: January 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Heart Valve Diseases
• Tricuspid Valve Insufficiency
• Tricuspid Valve Regurgitation

Intervention

Device:
• Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)	Québec
Canada	St. Michael's Hospital	Toronto	Ontario
Canada	St. Paul's Hospital Vancouver	Vancouver	British Columbia
France	CHU Bordeaux, Hôpital Cardiologique Haut Lévêque	Pessac
France	Clinique Pasteur	Toulouse
Switzerland	InselSpital University Hospital Bern	Bern
Switzerland	Universitätsspital Zürich	Zürich
United States	Emory University	Atlanta	Georgia
United States	Piedmont Heart Institute	Atlanta	Georgia
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital Boston	Boston	Massachusetts
United States	Montefiore Medical Center	Bronx	New York
United States	University of Virginia Health System	Charlottesville	Virginia
United States	Henry Ford Hospital	Detroit	Michigan
United States	Northwestern University	Evanston	Illinois
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Intermountain Medical Center	Murray	Utah
United States	Columbia University Irving Medical Center / NYPH	New York	New York
United States	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania
United States	Baylor Heart Hopsital Plano	Plano	Texas
United States	Oregon Health & Science University	Portland	Oregon
United States	Stanford University	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Countries where clinical trial is conducted

United States,  Canada,  France,  Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from device or procedure-related adverse events [Time Frame: 30 days]	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, 12 months, annual for five years
Secondary	Reduction in TR grade	Number of patients with reduction in TR from baseline	30 days, 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, 12 months, annual for five years
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, 12 months, annual for five years