Edwards CLASP TR EFS (CLASP TR EFS)
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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. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03745313 |
Recruitment Status :
Active, not recruiting
First Posted : November 19, 2018
Last Update Posted : May 13, 2022
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tricuspid Regurgitation | Device: Transcatheter Tricuspid Valve Repair | Not Applicable |
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 |
Actual Primary Completion Date : | May 11, 2021 |
Estimated Study Completion Date : | May 31, 2026 |
Arm | Intervention/treatment |
---|---|
Experimental: Treatment
Treatment with the Edwards PASCAL Transcatheter Valve Repair System
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Device: Transcatheter Tricuspid Valve Repair
Repair of the tricuspid valve through a transcatheter approach
Other Name: Edwards PASCAL Transcatheter Valve Repair System |
- Freedom from device or procedure-related adverse events [ Time Frame: 30 days ]Safety assessed by freedom from device or procedure-related adverse events
- NYHA Functional Class [ Time Frame: 30 days, 6 Months, 12 Months, annual for five years ]Number of patients with improvement in NYHA class
- Six minute walk test [ Time Frame: 30 days , 6 months, 1 year ]Change in distance (m) from baseline
- 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
- 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
- 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)

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

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
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 |
Principal Investigator: | Susheel K. Kodali, MD | Columbia University |
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 13, 2022 |
Last Verified: | May 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
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 |
Functional TR FTR Transcatheter |
Repair Regurgitation Degenerative |
Tricuspid Valve Insufficiency Heart Valve Diseases Heart Diseases Cardiovascular Diseases |