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2019-06 TRISCEND Study

2019-06 TRISCEND Study

Recruiting
18 years and older
All
Phase N/A

Overview

Early feasibility study to assess safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Description

The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Edwards EVOQUE Tricuspid Valve Replacement System

Eligibility

Inclusion Criteria:

  • Functional or degenerative TR moderate or greater
  • Symptomatic despite medical therapy
  • The Local Site Heart Team determines that the patient is appropriate for transcatheter tricuspid valve replacement

Exclusion Criteria:

  • Unsuitable anatomy
  • Previous tricuspid valve repair or replacement
  • Comorbid 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 details
    Tricuspid Regurgitation
    Heart disease
    Heart disease
    VALVULAR HEART DISEASE
    Cardiovascular Disease

NCT04221490

Edwards Lifesciences

16 February 2024

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