2019-06 TRISCEND Study

NCT04221490 | Active Not Recruiting Results DMC FDA Device

• 1 other identifier: 2019-06
• Study Type: interventional
• Target: 228
• Locations: 4 countries
• Sites: 20

Brief Summary

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

Conditions

Cardiovascular Diseases; Tricuspid Valve Regurgitation; Heart Valve Diseases

Keywords

Tricuspid Regurgitation; Transcatheter; Replacement; Functional; Degenerative; Regurgitation; Valve Replacement; Cardiovascular Disease

Outcome Measures

Primary Outcomes (5)

• Composite Major Adverse Events (MAEs)

  Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction, stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency tricuspid valve re-intervention, major access site and vascular complications, major access site and vascular complications, and device-related pulmonary embolism at 30 days.

  30 Days

• Device Success

  Study device is deployed as intended and the delivery system is successfully retrieved as intended at the time of the patient's exit from the cardiac catheterization laboratory.

  Intraprocedural

• Procedure Success

  Device success without clinically significant paravalvular leak (PVL) on a transthoracic echocardiogram (assessed by the echo core lab) at time of discharge.

  Discharge (Up to 7 days post procedure)

• Clinical Success

  Procedural success without MAEs at 30 days.

  30 Days

• Tricuspid Regurgitation Reduction

  Percentage of patients with at least 1 grade reduction in tricuspid regurgitation (TR) as measured by using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.

  Discharge (Up to 7 days post procedure)

Secondary Outcomes (10)

• Tricuspid Regurgitation (TR) Grade

  Baseline, 30 Days, 6 Months

• New York Heart Association (NYHA) Functional Class

  Baseline, 30 Days, 6 Months

• Change in Six Minute Walk Test (6WMT) Distance

  30 Days, 6 Months

• Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)

  30 Days, 6 Months

• Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score

  30 Days, 6 Months

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the Edwards EVOQUE Tricuspid Valve Replacement System

Device: Transcatheter Tricuspid Valve Replacement

Interventions

Transcatheter Tricuspid Valve Replacement DEVICE

Replacement of the tricuspid valve through a transcatheter approach

Also known as: Edwards EVOQUE Tricuspid Valve Replacement System

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Edwards Lifesciences: lead

Study Sites (20)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Stanford University

Stanford, California, 94305, United States

Location

Emory University

Atlanta, Georgia, 30308, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Massachusetts General Hospital Boston

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Columbia University Irving Medical Center / NYPH

New York, New York, 10032, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Hospital of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor Heart Hopsital Plano

Plano, Texas, 75093, United States

Location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

St. Paul's Hospital Vancouver

Vancouver, British Columbia, V6Z1Y6, Canada

Location

St. Michael's Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)

Québec, G1V 4G5, Canada

Location

CHU Bordeaux, Hôpital Cardiologique Haut Lévêque

Pessac, 33600, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

InselSpital University Hospital Bern

Bern, 3010, Switzerland

Location

Related Publications (2)

• 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.

  PMID: 37930776 BACKGROUND

• 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.

  PMID: 35272771 BACKGROUND

MeSH Terms

Conditions

Tricuspid Valve Insufficiency; Heart Valve Diseases; Cardiovascular Diseases; Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Heart Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Results Point of Contact

• Title: Ted Feldman
• Organization: Edwards Lifesciences

Feldman_Info@edwards.com

949-250-2500

Study Officials

• Susheel Kodali, MD

  Columbia University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2020
• First Posted: January 9, 2020
• Study Start: May 6, 2020
• Primary Completion: January 5, 2024
• Study Completion (Estimated): January 31, 2029
• Last Updated: January 9, 2026
• Results First Posted: January 9, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (14); FR (2); CH (1); CA (3)