2019-06 TRISCEND Study

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Cardiovascular Diseases; Heart Valve Diseases; Tricuspid Valve Regurgitation
• Intervention / Treatment: Device: Transcatheter Tricuspid Valve Replacement

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 Type: Interventional
• Enrollment (Actual): 228
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Québec, Canada, G1V 4G5
    • Institut universitaire de cardiologie et de pneumologie de Québec - Université Laval (IUCPQ-ULaval)
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z1Y6
      • St. Paul's Hospital Vancouver
  • Ontario
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
• France
  • Pessac, France, 33600
    • CHU Bordeaux, Hôpital Cardiologique Haut Lévêque
  • Toulouse, France, 31076
    • Clinique Pasteur
• Switzerland
  • Bern, Switzerland, 3010
    • InselSpital University Hospital Bern
• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Stanford, California, United States, 94305
      • Stanford University
  • Georgia
    • Atlanta, Georgia, United States, 30308
      • Emory University
    • Atlanta, Georgia, United States, 30309
      • Piedmont Heart Institute
  • Illinois
    • Evanston, Illinois, United States, 60208
      • Northwestern University
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital Boston
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • New York
    • New York, New York, United States, 10032
      • Columbia University Irving Medical Center / NYPH
    • The Bronx, New York, United States, 10467
      • Montefiore Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Texas
    • Plano, Texas, United States, 75093
      • Baylor Heart Hopsital Plano
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with the Edwards EVOQUE Tricuspid 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tricuspid Regurgitation (TR) Grade	Tricuspid regurgitation (TR) is measured by transthoracic echocardiogram (TTE) at each visit using a 5-grade classification system (mild, moderate, severe, massive, torrential). TR grade is assessed by an independent echocardiography core laboratory.	Baseline, 30 Days, 6 Months
New York Heart Association (NYHA) Functional Class	NYHA Functional Classification - The stages of heart failure: Class I - No symptoms and no limitation in ordinary physical activity Class II - Mild symptoms and slight limitation during ordinary activity. Class III - Marked limitation in activity due to symptoms, even during less-than-ordinary activity. Comfortable only at rest. Class IV - Severe limitations. Experiences symptoms even while at rest.	Baseline, 30 Days, 6 Months
Change in Six Minute Walk Test (6WMT) Distance	Mean distance in meters walked during Six Minute Walk Test (6MWT) at each follow-up visit compared to baseline. 6MWT is a submaximal exercise test that measures the distance that a patient can walk on a flat surface in a period of 6 minutes.	30 Days, 6 Months
Change in Quality of Life Score as Measured by Kansas City Cardiomyopathy Questionnaire (KCCQ)	Mean KCCQ score at each follow-up visit compared to baseline. The KCCQ is a 23-item, self-administered instrument that quantifies physical function, symptoms (frequency, severity and recent change), social function, self-efficacy and knowledge, and quality of life. Scores range from 0-100, in which higher scores reflect better health status.	30 Days, 6 Months
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Mental Score	Mean change in SF-36 mental score at each follow-up visit compared to baseline compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The mental health measure is composed of vitality (4 items), social functioning (2 items), role-emotional (3 items), and mental health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	30 Days, 6 Months
Change in Quality of Life as Measured by 36-Item Short Form Health Survey (SF-36) Physical Score	Mean change in SF-36 physical score at each follow-up visit compared to baseline. The SF-36 questionnaire consists of eight scales yielding two summary measures: physical and mental health. The physical health measure includes four scales of physical functioning (10 items), role-physical (4 items), bodily pain (2 items), and general health (5 items). Scores are transformed to a range of 0-100, in which higher scores reflect better health status.	30 Days, 6 Months
Change in Body Weight	Mean change in body weight in kilograms at each follow-up visit compared to baseline.	30 Days, 6 Months
Change in Left Ankle Circumference	Mean change in left ankle circumference in centimeters at each follow-up visit compared to baseline.	30 Days, 6 Months
Change in Right Ankle Circumference	Mean change in right ankle circumference in centimeters at each follow-up visit compared to baseline.	30 Days, 6 Months
Edema Assessment By Visit	The edema grading scale measures how quickly the dimple goes back to normal (rebound) after a pitting test. The scale includes: Grade 1: Immediate rebound with 0 to 2 millimeter (mm) pit. Grade 2: Less than 15-second rebound with 3 to 4 mm pit. Grade 3: Rebound greater than 15 seconds but less than 60 seconds with 5 to 6 mm pit. Grade 4: Rebound between 2 to 3 minutes with an 8 mm pit.	Baseline, 30 Days, 6 Months

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Susheel Kodali, MD, Columbia University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2020
• Primary Completion (Actual): January 5, 2024
• Study Completion (Estimated): January 31, 2029

Study Registration Dates

• First Submitted: January 6, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (Actual): January 9, 2020

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 6, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Replacement; Cardiovascular Disease; Degenerative; Regurgitation; Functional; Transcatheter; Valve Replacement; Tricuspid Regurgitation
• Additional Relevant MeSH Terms: Heart Diseases; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Cardiovascular Diseases; Tricuspid Valve Insufficiency; Gastroesophageal Reflux; Heart Valve Diseases
• Other Study ID Numbers: 2019-06

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes