Edwards CLASP TR EFS

Not Applicable

Completed

• Conditions: Tricuspid Regurgitation

• Registration Number: NCT03745313
• Lead Sponsor: Edwards Lifesciences

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-11-13
• Study First Submitted QC: 2018-11-15
• Study First Posted: 2018-11-19
• Study Start: 2019-02-05
• Primary Completion: 2021-05-11
• Disposition First Submitted: 2022-05-10
• Results First Submitted: 2024-05-10
• Results First Submitted QC: 2024-10-01
• Results First Posted: 2024-10-09
• Disposition First Posted: 2024-10-09
• Study Completion: 2025-05-13
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-14
• Last Update Posted: 2025-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Composite Major Adverse Event (MAE) Rate	30 days	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.

Secondary Outcome Measures

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

Trial Locations

Locations (15)

Cedars Sinai Medical Center; 🇺🇸 Los Angeles, California, United States

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

St. Vincent Heart Center of Indiana; 🇺🇸 Indianapolis, Indiana, United States

Henry Ford Hospital; 🇺🇸 Detroit, Michigan, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Morristown Medical Center; 🇺🇸 Morristown, New Jersey, United States

NYU Langone Health; 🇺🇸 New York, New York, United States

Columbia University Medical Center/New York Presbyterian Hospital; 🇺🇸 New York, New York, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

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