Skip to main content
OpenTrials
Completed

NCT Number: NCT03745313

Edwards CLASP TR EFS

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Tricuspid Regurgitation Cardiovascular Diseases Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastroesophageal Reflux Gastrointestinal Diseases Heart Diseases Heart Valve Diseases Tricuspid Valve Insufficiency

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars Sinai Medical Center, Los Angeles, California, United States

Loading trial locations.

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Edwards PASCAL Transcatheter Valve Repair System

Device

Repair of the tricuspid valve through a transcatheter approach

Primary outcomes

  1. Composite Major Adverse Event (MAE) Rate

    Time frame: 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 outcomes

  1. Device Success

    Time frame: Intraprocedural

    Number and percentage of Device Success, definition modified from MVARC criteria. Per device analysis

  2. Procedural Success

    Time frame: Discharge (2-7 days)

    Number and percentage of patients who had Procedural Success, definition modified from MVARC criteria. Per patient analysis

  3. Clinical Success

    Time frame: 30 days

    Number and percentage of patients who had procedural success without MAEs at 30 days. Per patient analysis

Sponsors and collaborators

Lead sponsor

Edwards Lifesciences

Industry

Registry information

Official study title

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

Acronym: CLASP TR EFS

Important dates

Study start
2019
Primary completion
2021
Study completion
2025
First posted
Nov 19, 2018
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.