Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    NCT04482062
Previous Study | Return to List | Next Study

TRISCEND II Pivotal Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04482062
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Brief Summary:
Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system

Condition or disease Intervention/treatment Phase
Tricuspid Valve Regurgitation Tricuspid Valve Insufficiency Tricuspid Valve Disease Heart Valve Diseases Cardiovascular Diseases Heart Failure Device: Edwards EVOQUE System Drug: Optimal Medical Therapy Not Applicable

Detailed Description:
The study is a prospective, multi-center, randomized controlled pivotal clinical trial to evaluate the safety and effectiveness of the EVOQUE System with optimal medical therapy (OMT) compared to OMT alone in the treatment of patients with at least severe tricuspid regurgitation. Subjects will be followed at discharge, 30 days, 3 months, 6 months and annually through 5 years.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 775 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Actual Study Start Date : April 9, 2021
Estimated Primary Completion Date : June 2024
Estimated Study Completion Date : June 2028

Arm Intervention/treatment
Experimental: Edwards EVOQUE System & OMT
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation
Device: Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Other Name: Transcatheter tricuspid valve replacement

Active Comparator: Optimal Medical Therapy (OMT)
Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
Drug: Optimal Medical Therapy
Optimal Medical Therapy

Experimental: Single-Arm Registry
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation who are not eligible for randomization
Device: Edwards EVOQUE System
Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
Other Name: Transcatheter tricuspid valve replacement




Primary Outcome Measures :
  1. TR Grade reduction and composite endpoint including: Kansas City Cardiomyopathy Questionnaire (KCCQ) improvement, New York Heart Association (NYHA) functional class improvement, and 6-minute walk test distance improvement [ Time Frame: 6 months ]
    Comparison of number of participants with reduction in TR and composite endpoint event improvement between experimental and active comparator arms

  2. Rate of Major Adverse Events (MAE) [ Time Frame: 30 days ]
    Rate of Major Adverse Events (MAE) in experimental arm

  3. Composite endpoint including all-cause mortality, RVAD implantation or heart transplant, tricuspid valve intervention, heart failure hospitalizations, KCCQ improvement, NYHA functional class improvement, and 6-minute walk distance improvement [ Time Frame: 1 year ]
    Comparison of number of participants with composite endpoint events between experimental and active comparator arms


Secondary Outcome Measures :
  1. Composite endpoint including reduction in TR grade, change in QOL from baseline, death and heart failure hospitalization, all-cause hospitalization, all-cause mortality, and change in right ventricular end diastolic volume index [ Time Frame: 1 year ]
    Hierarchical comparison of number of participants with composite endpoint events between experimental and active comparator arms



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Symptomatic tricuspid regurgitation (TR) despite medical therapy
  • TR graded as severe or greater
  • Appropriate for transcatheter tricuspid valve replacement per the local heart team

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04482062


Contacts
Layout table for location contacts
Contact: TMTT Clinical 949-250-2500 or 800-424-3278 TMTT_Clinical@Edwards.com

Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Principal Investigator: Raj Makkar, MD         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30308
Principal Investigator: Vasilis Babaliaros, MD         
United States, Illinois
Northwestern University Recruiting
Chicago, Illinois, United States, 60611
Principal Investigator: Charles Davidson, MD         
United States, Maryland
University of Maryland Recruiting
Baltimore, Maryland, United States, 21201
Principal Investigator: Murtaza Dawood, MD         
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Principal Investigator: Sammy Elmariah, MD         
United States, Michigan
Henry Ford Health System Recruiting
Detroit, Michigan, United States, 48202
Principal Investigator: William O'Neill, MD         
United States, New Jersey
Morristown Medical Center Recruiting
Morristown, New Jersey, United States, 07960
Principal Investigator: Robert Kipperman, MD         
Rutgers Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08903
Principal Investigator: Mark Russo, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10461
Principal Investigator: M. Azeem Latib, MD         
Columbia University Medical Center/NYPH Recruiting
New York, New York, United States, 10032
Principal Investigator: Susheel Kodali, MD         
United States, Ohio
The Christ Hospital Recruiting
Cincinnati, Ohio, United States, 45219
Principal Investigator: Ian Sarembock, MD         
Principal Investigator: Joseph Choo, MD         
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97293
Principal Investigator: Firas Zahr, MD         
Principal Investigator: Scott Chadderdon, MD         
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Principal Investigator: Colin Barker, MD         
Principal Investigator: Brian Lindman, MD         
United States, Texas
Baylor Heart Hopsital Plano Recruiting
Plano, Texas, United States, 75093
Principal Investigator: Robert Smith, MD         
Principal Investigator: Molly Szerlip, MD         
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Principal Investigator: Scott Lim, MD         
Sponsors and Collaborators
Edwards Lifesciences
Investigators
Layout table for investigator information
Principal Investigator: James Gammie, MD Johns Hopkins Health System
Principal Investigator: Rebecca Hahn, MD Columbia University
Principal Investigator: Susheel Kodali, MD Columbia University
Layout table for additonal information
Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04482062    
Other Study ID Numbers: 2020-05
First Posted: July 22, 2020    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases