Edwards CLASP TR EFS

Edwards Lifesciences65 enrolled

Overview

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

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Tricuspid Regurgitation

Interventions

Edwards PASCAL Transcatheter Valve Repair SystemDEVICE

Repair of the tricuspid valve through a transcatheter approach

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (15)

Cedars Sinai Medical Center

Los Angeles, California, United States

Emory University Hospital

Atlanta, Georgia, United States

Outcomes

Primary Outcomes

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.

Time frame: 30 days

Secondary Outcomes

Device Success

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

Time frame: Intraprocedural

Procedural Success

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

Time frame: Discharge (2-7 days)

Clinical Success

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

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.