Edwards CLASP TR EFS (CLASP TR EFS)

Edwards PASCAL TrAnScatheter Valve RePair System in Tricuspid Regurgitation (CLASP TR) Early Feasibility Study

Early feasibility study to assess the safety and performance of the Edwards PASCAL Transcatheter Valve Repair System in tricuspid regurgitation

Study Overview

• Status: Completed
• Conditions: Tricuspid Regurgitation
• Intervention / Treatment: Device: Edwards PASCAL Transcatheter Valve Repair System

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 Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Cedars Sinai Medical Center
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
  • Indiana
    • Indianapolis, Indiana, United States, 46290
      • St. Vincent Heart Center of Indiana
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55902
      • Mayo Clinic
  • New Jersey
    • Morristown, New Jersey, United States, 07960
      • Morristown Medical Center
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health
    • New York, New York, United States, 10032
      • Columbia University Medical Center/New York Presbyterian Hospital
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Wynnewood, Pennsylvania, United States, 19096
      • Lankenau Medical Center
  • Texas
    • Plano, Texas, United States, 75093
      • The Heart Hospital Baylor Plano
  • Utah
    • Murray, Utah, United States, 84107
      • Intermountain Medical Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Health System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with the Edwards PASCAL Transcatheter Valve Repair System	Device: Edwards PASCAL Transcatheter Valve Repair System; Repair of the tricuspid valve through a transcatheter approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Device Success	Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis	Intraprocedural
Procedural Success	Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis	Discharge (2-7 days)
Clinical Success	Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis	30 days

Collaborators and Investigators

• Sponsor: Edwards Lifesciences
• Investigators: Principal Investigator: Susheel K. Kodali, MD, Columbia University

Publications and helpful links

General Publications

• Kodali 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 5, 2019
• Primary Completion (Actual): May 11, 2021
• Study Completion (Actual): May 13, 2025

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: November 15, 2018
• First Posted (Actual): November 19, 2018

Study Record Updates

• Last Update Posted (Estimated): September 29, 2025
• Last Update Submitted That Met QC Criteria: September 25, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Degenerative; Regurgitation; Functional; Transcatheter; Repair; FTR; TR
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Heart Diseases; Digestive System Diseases; Gastrointestinal Diseases; Heart Valve Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Tricuspid Valve Insufficiency; Gastroesophageal Reflux
• Other Study ID Numbers: 2018-10

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes