Active — Not RecruitingNot Applicable

Amplatzer Amulet LAAO vs. NOAC

United States, Australia, Canada2,650 participantsStarted 2020-07-07

Plain-language summary

The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder) * At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women * Eligible for long-term NOAC therapy * Able to comply with the required NOAC medication regimen if randomized to the Control Group * Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in * Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment * 18 years of age or older, or the age of legal consent * Able and willing to return for required follow-up visits and assessments Exclusion Criteria: * Requires long-term OAC therapy for a condition other than AF * Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable) * Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use * Indicated for P2Y12 platelet inhibitor for \>1 year post-randomization * In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure * Has undergone atrial septal d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Composite of ischemic stroke, systemic embolism, or cardiovascular (CV) mortality

Timeframe: 2 years

Major bleeding or clinically relevant non-major bleeding (CRNMB) events, excluding procedure related events

Timeframe: 2 years

Composite of ischemic stroke or systemic embolism

Timeframe: 3 years

Trial details

NCT IDNCT04226547

SponsorAbbott Medical Devices

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2029-01

View on ClinicalTrials.gov More Atrial Fibrillation trials