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TVMR With the Innovalve System Trial - First In Human Israel

Recruiting
18 years of age
Both
Phase N/A
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Overview

Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Description

The study is a multi-center, First-In-Human, prospective, single arm early feasibility study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Eligibility

Inclusion Criteria:

  • Clinically significant, symptomatic mitral regurgitation
  • High risk for open-heart surgery
  • Meets anatomical criteria

Exclusion Criteria:

  • Unsuitable anatomy
  • Patient is inoperable
  • EF<25%

Study details

Mitral Valve Regurgitation (Degenerative or Functional)

NCT05688514

Innovalve Bio Medical Ltd.

8 March 2024

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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