Clinical trial NCT04221490: 2019-06 TRISCEND Study
Official title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Tricuspid Valve Regurgitation
Heart Valve Diseases
Cardiovascular Diseases
Keywords: Tricuspid Regurgitation
Transcatheter
Replacement
Functional
Degenerative
Regurgitation
Valve Replacement
Cardiovascular Disease
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2020-01-09
Enrollment: 228
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite Major Adverse Events (MAEs)
timeFrame: 30 Days
measure: Device Success
timeFrame: Intraprocedural
measure: Procedure Success
timeFrame: Discharge (Up to 7 days post procedure)
measure: Clinical Success
timeFrame: 30 Days
measure: Tricuspid Regurgitation Reduction
timeFrame: Discharge (Up to 7 days post procedure)
Secondary outcomes:
measure: Tricuspid Regurgitation (TR) Grade
timeFrame: Baseline, 30 Days, 6 Months
measure: New York Heart Association (NYHA) Functional Class
timeFrame: Baseline, 30 Days, 6 Months
measure: Change in Six Minute Walk Test (6WMT) Distance
timeFrame: 30 Days, 6 Months
measure: Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)
timeFrame: 30 Days, 6 Months
measure: Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score
timeFrame: 30 Days, 6 Months
measure: Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score
timeFrame: 30 Days, 6 Months
measure: Change in Body Weight
timeFrame: 30 Days, 6 Months
measure: Change in Left Ankle Circumference
timeFrame: 30 Days, 6 Months
measure: Change in Right Ankle Circumference
timeFrame: 30 Days, 6 Months
measure: Edema Assessment By Visit
timeFrame: Baseline, 30 Days, 6 Months
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Stanford
country: United States
facility: Stanford University
state: California
city: Atlanta
country: United States
facility: Emory University
state: Georgia
city: Atlanta
country: United States
facility: Piedmont Heart Institute
state: Georgia
city: Evanston
country: United States
facility: Northwestern University
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital Boston
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Bronx
country: United States
facility: Montefiore Medical Center
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center / NYPH
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Plano
country: United States
facility: Baylor Heart Hopsital Plano
state: Texas
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Vancouver
country: Canada
facility: St. Paul's Hospital Vancouver
state: British Columbia
city: Toronto
country: Canada
facility: St. Michael's Hospital
state: Ontario
city: Québec
country: Canada
facility: Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
city: Pessac
country: France
facility: CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
city: Toulouse
country: France
facility: Clinique Pasteur
city: Bern
country: Switzerland
facility: InselSpital University Hospital Bern
Study officials:
affiliation: Columbia University
name: Susheel Kodali, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kodali S, Hahn RT, Makkar R, Makar M, Davidson CJ, Puthumana JJ, Zahr F, Chadderdon S, Fam N, Ong G, Yadav P, Thourani V, Vannan MA, O'Neill WW, Wang DD, Tchetche D, Dumonteil N, Bonfils L, Lepage L, Smith R, Grayburn PA, Sharma RP, Haeffele C, Babaliaros V, Gleason PT, Elmariah S, Inglessis-Azuaje I, Passeri J, Herrmann HC, Silvestry FE, Lim S, Fowler D, Webb JG, Moss R, Modine T, Lafitte S, Latib A, Ho E, Goldberg Y, Shah P, Nyman C, Rodes-Cabau J, Bedard E, Brugger N, Sannino A, Mack MJ, Leon MB, Windecker S; the TRISCEND study investigators. Transfemoral tricuspid valve replacement and one-year outcomes: the TRISCEND study. Eur Heart J. 2023 Dec 7;44(46):4862-4873. doi: 10.1093/eurheartj/ehad667.
citation: Kodali S, Hahn RT, George I, Davidson CJ, Narang A, Zahr F, Chadderdon S, Smith R, Grayburn PA, O'Neill WW, Wang DD, Herrmann H, Silvestry F, Elmariah S, Inglessis I, Passeri J, Lim DS, Salerno M, Makar M, Mack MJ, Leon MB, Makkar R; TRISCEND Investigators. Transfemoral Tricuspid Valve Replacement in Patients With Tricuspid Regurgitation: TRISCEND Study 30-Day Results. JACC Cardiovasc Interv. 2022 Mar 14;15(5):471-480. doi: 10.1016/j.jcin.2022.01.016.