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Clinical Trial to Evaluate the Safety and Effectiveness of Using the Tendyne Transcatheter Mitral Valve System for the Treatment of Symptomatic Mitral Regurgitation

Study to test the safety and effectiveness of Tendyne Mitral Valve.

Recruiting
18 years and older
All
Phase N/A

This clinical trial is testing the Tendyne Transcatheter Mitral Valve System, a device for treating symptomatic mitral regurgitation, which is when the heart's mitral valve doesn't close tightly, causing blood to flow backward. The study will compare the Tendyne system to the MitraClip System, another device used for this condition. Patients will be placed into different groups based on their specific condition and needs. The study is looking for patients who have moderate-to-severe or severe mitral regurgitation or severe mitral annular calcification (MAC), which is calcium buildup around the valve.

Participants will be monitored from before the procedure to 5 years after, with visits at 30 days, 3 months, 6 months, and yearly. Eligible patients should have symptoms like difficulty breathing or fatigue and must not have other severe heart issues or be in a vulnerable population.

  • Study lasts up to 5 years with multiple check-ups.
  • Potential benefits include improved heart function.
  • Risks related to the procedure and device use.
Study details
    Mitral Regurgitation
    Mitral Insufficiency
    Mitral Valve Insufficiency
    Cardiovascular Diseases
    Valve Disease
    Heart
    Heart Valve Diseases
    Functional Mitral Regurgitation
    Degenerative Mitral Valve Disease

NCT03433274

Abbott Medical Devices

31 March 2025

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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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