2019-06 TRISCEND Study

Sponsor

Edwards Lifesciences (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04221490

Collaborator

(none)

200

Enrollment

Locations

Arm

66.9

Anticipated Duration (Months)

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Condition or Disease	Intervention/Treatment	Phase
Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases	Device: Transcatheter Tricuspid Valve Replacement	N/A

Detailed 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

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

May 6, 2020

Anticipated Primary Completion Date :

Oct 1, 2025

Anticipated Study Completion Date :

Dec 1, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System	Device: Transcatheter Tricuspid Valve Replacement Replacement of the tricuspid valve through a transcatheter approach Other Names: Edwards EVOQUE Tricuspid Valve Replacement System

Arm

Intervention/Treatment

Experimental: Treatment

Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System

Device: Transcatheter Tricuspid Valve Replacement

Replacement of the tricuspid valve through a transcatheter approach

Other Names:

Edwards EVOQUE Tricuspid Valve Replacement System

Outcome Measures

Primary Outcome Measures

Freedom from device or procedure-related adverse events [ Time Frame: 30 days ] [30 days]
Freedom from device or procedure-related adverse events

Secondary Outcome Measures

NYHA Functional Class [30 days, 6 months, 12 months, annual for five years]
Number of patients with improvement in NYHA class
Six minute walk test [30 days, 6 months, 12 months, annual for five years]
Change in distance (m) from baseline
Reduction in TR grade [30 days, 6 months, 12 months, annual for five years]
Number of patients with reduction in TR from baseline
Health Status - KCCQ [30 days, 6 months, 12 months, annual for five years]
Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire
Health Status - SF-36 [30 days, 6 months, 12 months, annual for five years]
Number of points of improvement in health status as measured by 36 item short form survey (SF-36)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cedars-Sinai Medical Center	Los Angeles	California	United States	90048
2	Stanford University	Stanford	California	United States	94305
3	Emory University	Atlanta	Georgia	United States	30308
4	Piedmont Heart Institute	Atlanta	Georgia	United States	30309
5	Northwestern University	Evanston	Illinois	United States	60208
6	University of Maryland	Baltimore	Maryland	United States	21201
7	Massachusetts General Hospital Boston	Boston	Massachusetts	United States	02114
8	Brigham and Women's Hospital	Boston	Massachusetts	United States	02115
9	Henry Ford Hospital	Detroit	Michigan	United States	48202
10	Morristown Medical Center	Morristown	New Jersey	United States	07960
11	Montefiore Medical Center	Bronx	New York	United States	10467
12	Columbia University Irving Medical Center / NYPH	New York	New York	United States	10032
13	Cleveland Clinic	Cleveland	Ohio	United States	44195
14	Oregon Health & Science University	Portland	Oregon	United States	97239
15	Hospital of the University of Pennsylvania	Philadelphia	Pennsylvania	United States	19104
16	Baylor Heart Hopsital Plano	Plano	Texas	United States	75093
17	Intermountain Medical Center	Murray	Utah	United States	84107
18	University of Virginia Health System	Charlottesville	Virginia	United States	22908
19	St. Paul's Hospital Vancouver	Vancouver	British Columbia	Canada	V6Z1Y6
20	St. Michael's Hospital	Toronto	Ontario	Canada	M5B 1W8
21	Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)	Québec		Canada	G1V 4G5
22	CHU Bordeaux, Hôpital Cardiologique Haut Lévêque	Pessac		France	33600
23	Clinique Pasteur	Toulouse		France	31076
24	InselSpital University Hospital Bern	Bern		Switzerland	3010
25	Universitätsspital Zürich	Zürich		Switzerland	CH-8091