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2019-06 TRISCEND Study

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ClinicalTrials.gov Identifier: NCT04221490
Recruitment Status : Recruiting
First Posted : January 9, 2020
Last Update Posted : August 30, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Condition or disease Intervention/treatment Phase
Tricuspid Valve Regurgitation Heart Valve Diseases Cardiovascular Diseases Device: Transcatheter Tricuspid Valve Replacement Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards EVOQUE Tricuspid Valve Replacement: Investigation of Safety and Clinical Efficacy After Replacement of Tricuspid Valve With Transcatheter Device
Actual Study Start Date : May 6, 2020
Estimated Primary Completion Date : October 2025
Estimated Study Completion Date : December 2025
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards EVOQUE Tricuspid Transcatheter Valve Replacement System
 Device: Transcatheter Tricuspid Valve Replacement
Replacement of the tricuspid valve through a transcatheter approach
Other Name: Edwards EVOQUE Tricuspid Valve Replacement System


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from device or procedure-related adverse events [ Time Frame: 30 days ] [ Time Frame: 30 days ]
    Freedom from device or procedure-related adverse events


Secondary Outcome Measures :
  1. NYHA Functional Class [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Number of patients with improvement in NYHA class

  2. Six minute walk test [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Change in distance (m) from baseline

  3. Reduction in TR grade [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Number of patients with reduction in TR from baseline

  4. Health Status - KCCQ [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Number of points of improvement in health status as measured by Kansas City Cardiomyopathy Questionnaire

  5. Health Status - SF-36 [ Time Frame: 30 days, 6 months, 12 months, annual for five years ]
    Number of points of improvement in health status as measured by 36 item short form survey (SF-36)


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

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

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
Contacts and Locations
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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): NCT04221490


Contacts
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Contact: TMTT Clinical 949-250-2500 TMTT_Clinical@Edwards.com

Locations
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Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Susheel Kodali, MD Columbia University
More Information
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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT04221490    
Other Study ID Numbers: 2019-06
First Posted: January 9, 2020    Key Record Dates
Last Update Posted: August 30, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Edwards Lifesciences:
Tricuspid Regurgitation
Transcatheter
Replacement
Functional
 Degenerative
Regurgitation
Valve Replacement
Cardiovascular Disease
Additional relevant MeSH terms:
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Cardiovascular Diseases
Heart Valve Diseases
Tricuspid Valve Insufficiency
Heart Diseases