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Edwards CLASP TR EFS (CLASP TR EFS)

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ClinicalTrials.gov Identifier: NCT03745313
Recruitment Status : Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : May 17, 2021
Sponsor:
Information provided by (Responsible Party):
Edwards Lifesciences

Study Description
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Brief Summary:
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Condition or disease Intervention/treatment Phase
Tricuspid Regurgitation Device: Transcatheter Tricuspid Valve Repair Not Applicable

Detailed Description:
The study is a multi-center, prospective, single-arm, and non-randomized study designed to evaluate the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 65 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
Actual Study Start Date : February 5, 2019
Estimated Primary Completion Date : May 21, 2021
Estimated Study Completion Date : May 31, 2026
Arms and Interventions
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Arm Intervention/treatment
Experimental: Treatment
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
 Device: Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Other Name: Edwards PASCAL Transcatheter Valve Repair System


Outcome Measures
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Primary Outcome Measures :
  1. Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]
    Safety assessed by 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, 1 year ]
    Change in distance (m) from baseline

  3. Reduction in TR grade [ Time Frame: 30 days, 3 Months ,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, 1 year ]
    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, 1 year ]
    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:

  • Severe functional or degenerative TR
  • Symptomatic despite medical therapy
  • The local site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve repair

Exclusion Criteria:

  • Unsuitable anatomy
  • Previous tricuspid valve repair or replacement
  • Co-morbid condition(s) that, in the opinion of the investigator, could limit the patient's ability to participate in the study, including compliance with follow-up requirements, or that could impact the scientific integrity of the study
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): NCT03745313


Locations
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United States, California
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Indiana
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, United States, 46290
United States, Michigan
Henry Ford Hospital
Detroit, Michigan, United States, 48202
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55902
United States, New Jersey
Morristown Medical Center
Morristown, New Jersey, United States, 07960
United States, New York
NYU Langone Health
New York, New York, United States, 10016
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, United States, 10032
United States, Ohio
Cleveland Clinic
Cleveland, Ohio, United States, 44195
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Lankenau Medical Center
Wynnewood, Pennsylvania, United States, 19096
United States, Texas
The Heart Hospital Baylor Plano
Plano, Texas, United States, 75093
United States, Utah
Intermountain Medical Center
Murray, Utah, United States, 84107
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Edwards Lifesciences
Investigators
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Principal Investigator: Susheel K. Kodali, MD Columbia University
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Edwards Lifesciences
ClinicalTrials.gov Identifier: NCT03745313    
Other Study ID Numbers: 2018-10
First Posted: November 19, 2018    Key Record Dates
Last Update Posted: May 17, 2021
Last Verified: May 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:
Functional
TR
FTR
Transcatheter
 Repair
Regurgitation
Degenerative
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Valve Diseases
Heart Diseases
Cardiovascular Diseases