Edwards CLASP TR EFS
CLASP TR EFS
Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study
1 other identifier
interventional
65
1 country
15
Brief Summary
Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2019
Longer than P75 for not_applicable
15 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 13, 2018
CompletedFirst Posted
Study publicly available on registry
November 19, 2018
CompletedStudy Start
First participant enrolled
February 5, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 11, 2021
CompletedResults Posted
Study results publicly available
October 9, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
May 13, 2025
CompletedSeptember 29, 2025
September 1, 2025
2.3 years
November 13, 2018
May 10, 2024
September 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Composite Major Adverse Event (MAE) Rate
Number and percentage of patients who experienced at least one major adverse event (MAE). Composite of major adverse events (MAE) defined as cardiovascular mortality, myocardial infarction (MI), stroke, renal complications requiring unplanned dialysis or renal replacement therapy, severe bleeding, unplanned or emergency re-intervention related to the device, and major access site and vascular complications requiring intervention at 30 days.
30 days
Secondary Outcomes (3)
Device Success
Intraprocedural
Procedural Success
Discharge (2-7 days)
Clinical Success
30 days
Study Arms (1)
Treatment
EXPERIMENTALTreatment with the Edwards PASCAL Transcatheter Valve Repair System
Interventions
Repair of the tricuspid valve through a transcatheter approach
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (15)
Cedars Sinai Medical Center
Los Angeles, California, 90048, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Northwestern University
Chicago, Illinois, 60611, United States
St. Vincent Heart Center of Indiana
Indianapolis, Indiana, 46290, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Mayo Clinic
Rochester, Minnesota, 55902, United States
Morristown Medical Center
Morristown, New Jersey, 07960, United States
NYU Langone Health
New York, New York, 10016, United States
Columbia University Medical Center/New York Presbyterian Hospital
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
The Heart Hospital Baylor Plano
Plano, Texas, 75093, United States
Intermountain Medical Center
Murray, Utah, 84107, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Related Publications (2)
Kodali SK, Hahn RT, Davidson CJ, Narang A, Greenbaum A, Gleason P, Kapadia S, Miyasaka R, Zahr F, Chadderdon S, Smith RL, Grayburn P, Kipperman RM, Marcoff L, Whisenant B, Gonzales M, Makkar R, Makar M, O'Neill W, Wang DD, Gray WA, Abramson S, Hermiller J, Mitchel L, Lim DS, Fowler D, Williams M, Pislaru SV, Dahou A, Mack MJ, Leon MB, Eleid MF. 1-Year Outcomes of Transcatheter Tricuspid Valve Repair. J Am Coll Cardiol. 2023 May 9;81(18):1766-1776. doi: 10.1016/j.jacc.2023.02.049.
PMID: 37137586DERIVEDKodali S, Hahn RT, Eleid MF, Kipperman R, Smith R, Lim DS, Gray WA, Narang A, Pislaru SV, Koulogiannis K, Grayburn P, Fowler D, Hawthorne K, Dahou A, Deo SH, Vandrangi P, Deuschl F, Mack MJ, Leon MB, Feldman T, Davidson CJ; CLASP TR EFS Investigators. Feasibility Study of the Transcatheter Valve Repair System for Severe Tricuspid Regurgitation. J Am Coll Cardiol. 2021 Feb 2;77(4):345-356. doi: 10.1016/j.jacc.2020.11.047.
PMID: 33509390DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Ted Feldman
- Organization
- Edwards Lifesciences
Study Officials
- PRINCIPAL INVESTIGATOR
Susheel K. Kodali, MD
Columbia University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2018
First Posted
November 19, 2018
Study Start
February 5, 2019
Primary Completion
May 11, 2021
Study Completion
May 13, 2025
Last Updated
September 29, 2025
Results First Posted
October 9, 2024
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share