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TVMR With the Innovalve System Trial - Early Feasibility Study

Join our study to test a new heart valve treatment.

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18 years and older
All
Phase N/A
  • Simplified description (AI rewritten)
  • Technical description (Original)

Title: TVMR With the Innovalve System Trial - Early Feasibility Study

The study aims to test how safe and effective the Innovalve mitral valve replacement system is. This system is designed to help people with mitral regurgitation, which is when the heart's mitral valve doesn't close properly and can cause blood to flow backward inside the heart.

People who may join this study have to meet certain conditions. They should have a serious heart problem called symptomatic mitral regurgitation and be at high risk for traditional surgery. They also need to have a heart structure that fits the new device. However, if their heart shape isn't right, if they can't have surgery, or if their heart's pumping ability is too low (ejection fraction less than 25%), they cannot join.

  • This is a first-time test on humans, looking at safety and performance.
  • The study is held in multiple locations and only has one group of patients.
  • Consider your personal health conditions and risks before participating.
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Study details
    Mitral Valve Regurgitation (Degenerative or Functional)

NCT04919980

Edwards Lifesciences

26 April 2025

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  • You can expect the study team to contact you via email or phone in the next few days.
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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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