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Randomized Trial of the Neochord DS1000 System Versus Open Surgical Repair

"Testing Neochord DS1000 System vs. Open Surgery for Heart Valve Repair"

Recruiting
21 years and older
All
Phase N/A

This study is comparing two ways to fix a heart valve problem. The heart valve, called the mitral valve, is not closing properly in people with a condition known as degenerative mitral valve disease. One group will have a less invasive procedure using a device called the Neochord DS1000 System, which does not require stopping the heart (no cardiopulmonary bypass - a machine that takes over heart and lung function during surgery). The other group will have traditional surgery where the heart is stopped and a machine helps. This study wants to find out which method is safer and works better.

  • The study includes people with certain heart valve problems, but not those who had previous heart valve surgeries.
  • Participants will be randomly assigned to one of the two groups.
  • There may be risks involved, and participation is voluntary.

If you are considering participating, you should know that the study involves a heart procedure and you should talk to your doctor about potential benefits and risks.

Study details
    Mitral Valve Insufficiency

NCT02803957

NeoChord

13 December 2024

Step 1 Get in touch with the nearest study center
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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.

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