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TRISCEND II Pivotal Trial

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ClinicalTrials.gov Identifier: NCT04482062
Recruitment Status : Recruiting
First Posted : July 22, 2020
Last Update Posted : January 16, 2024
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Tracking Information
First Submitted Date  ICMJE July 9, 2020
First Posted Date  ICMJE July 22, 2020
Last Update Posted Date January 16, 2024
Actual Study Start Date  ICMJE April 9, 2021
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 23, 2020)
  • 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
  • Rate of Major Adverse Events (MAE) [ Time Frame: 30 days ]
    Rate of Major Adverse Events (MAE) in experimental arm
  • 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
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 23, 2020)		 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE TRISCEND II Pivotal Trial
Official Title  ICMJE Edwards EVOQUE Transcatheter Tricuspid Valve Replacement: Pivotal Clinical Investigation of Safety and Clinical Efficacy Using a Novel Device
Brief Summary Pivotal trial to evaluate the safety and effectiveness of the Edwards EVOQUE tricuspid valve replacement system
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tricuspid Valve Regurgitation
  • Tricuspid Valve Insufficiency
  • Tricuspid Valve Disease
  • Heart Valve Diseases
  • Cardiovascular Diseases
  • Heart Failure
Intervention  ICMJE
  • Device: Edwards EVOQUE System
    Transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with OMT
    Other Name: Transcatheter tricuspid valve replacement
  • Drug: Optimal Medical Therapy
    Optimal Medical Therapy
Study Arms  ICMJE
  • 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
    Intervention: Device: Edwards EVOQUE System
  • Active Comparator: Optimal Medical Therapy (OMT)
    Optimal medical therapy (OMT) alone in patients with tricuspid regurgitation
    Intervention: Drug: 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
    Intervention: Device: Edwards EVOQUE System
  • Experimental: Continued Access Study
    Provides continued access to transcatheter tricuspid valve replacement with the Edwards EVOQUE System in conjunction with optimal medical therapy (OMT) in patients with tricuspid regurgitation.
    Intervention: Device: Edwards EVOQUE System
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 5, 2023)		 1070
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE December 31, 2029
Estimated Primary Completion Date June 30, 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: TMTT Clinical 949-250-2500 or 800-424-3278 TMTT_Clinical@Edwards.com
Listed Location Countries  ICMJE Germany,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04482062
Other Study ID Numbers  ICMJE 2020-05
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Edwards Lifesciences
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Edwards Lifesciences
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Rebecca Hahn, MD Columbia University
Principal Investigator: Susheel Kodali, MD Columbia University
Principal Investigator: Philipp Lurz, MD Herzzentrum Leipzig GmbH
Principal Investigator: Vinod Thourani, MD Piedmont Heart Institute
PRS Account Edwards Lifesciences
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP