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TVMR With the Innovalve System Trial - Pilot Study in Italy

TVMR With the Innovalve System Trial - Pilot Study in Italy

Non Recruiting
18 years and older
All
Phase N/A
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  • Simplified (AI rewritten)

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Overview

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 <30%

Study details
    Mitral Valve Regurgitation (Degenerative or Functional)

NCT05010746

Innovalve Bio Medical Ltd.

20 August 2025

Contact a study center

FAQs

Learn more about clinical trials

What is a clinical trial?

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

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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