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Amplatzer Amulet LAAO Vs. NOAC

Comparing Amplatzer Amulet LAAO with NOAC in a clinical study.

Recruiting
18 years and older
All
Phase N/A

This study aims to compare two treatments for people with atrial fibrillation (AF), a common heart rhythm problem. One group will use the Amulet LAA occluder, a device that blocks a small part of the heart to prevent clots, and the other group will take a medication called NOAC (Non-Vitamin K Oral Anticoagulants), which helps prevent strokes by thinning the blood.

To join, you must be 18 or older, have AF, and be able to take NOACs or have the device implanted. You should be at a high risk for stroke, as shown by a specific score (CHA2DS2-VASc). You can't join if you need other blood thinners, have had recent heart problems, or have certain medical conditions.

  • The study is worldwide and will randomly assign participants to one of the two groups.
  • Participants must visit the doctor for follow-ups, and the study might last for a few years.
  • There may be risks like infection or reactions to the device or medication.

Consider if you can attend regular check-ups and if you meet the health criteria before deciding to participate.

Study details
    Atrial Fibrillation
    Stroke
    Bleeding

NCT04226547

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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