What side effects are associated with this type of intervention?

Common treatments for stroke prevention in non-valvular atrial fibrillation, such as left atrial appendage closure devices (e.g., Amulet™ and WATCHMAN®), can have side effects including procedural complications like bleeding, pericardial effusion, and device-related thromboembolism. Antiarrhythmic drugs like dronedarone, used to maintain sinus rhythm, may increase the risk of cardiovascular events, including stroke, myocardial infarction, and heart failure, especially in patients with permanent atrial fibrillation.

What prior FDA approvals exist?

The FDA has approved several treatments for stroke prevention, particularly in patients with non-valvular atrial fibrillation. One notable approval is the WATCHMAN® device, a left atrial appendage closure device designed to reduce the risk of stroke by preventing blood clots from forming in the left atrial appendage. This device serves as an alternative for patients who are contraindicated for long-term oral anticoagulation therapy. The Amulet™ device, currently under trial, aims to demonstrate non-inferiority to the WATCHMAN® device, offering another option for stroke prevention in similar patient populations.

What other types of research exist?

Promising alternatives to the Amulet™ device for left atrial appendage closure in 2024 include the WATCHMAN® device, which has been shown to be non-inferior in clinical trials. Other potential alternatives may include advancements in antiarrhythmic drugs and interventional approaches, though specific novel devices or treatments should be discussed with a healthcare provider based on the latest clinical data and individual patient needs.

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Left Atrial Appendage Occluder

AMPLATZER™ Amulet™ vs WATCHMAN Devices for Stroke Prevention (Amulet IDE Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for stroke prevention in patients with non-valvular atrial fibrillation, such as the Amulet™ device, involve left atrial appendage (LAA) closure. These devices work by occluding the LAA, which is a primary site for blood clot formation in AF patients. By sealing off the LAA, these devices prevent clots from entering the bloodstream and traveling to the brain, where they can cause a stroke. This mechanism is vital for stroke patients as it directly mitigates the risk of stroke by addressing the source of clot formation, offering an alternative to long-term anticoagulation therapy.

N/A

Waitlist Available

Research Sponsored by Abbott Medical Devices

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented paroxysmal, persistent, or permanent non-valvular atrial fibrillation (AF) without rheumatic mitral valvular heart disease

Suitable for short term warfarin therapy but unable to take long term oral anticoagulation

Must not have

Transient case of AF

Severe renal failure (estimated glomerular filtration rate <30ml/min/1.73m²)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 12-months

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing the Amulet™ device, which is designed to block a part of the heart to prevent blood clots in patients with non-valvular atrial fibrillation. The goal is to see if it works as well as another similar device called WATCHMAN®. Patients will receive either device and will be monitored over several years. The AMPLATZER Amulet™ device is being evaluated for its effectiveness in stroke prevention in comparison to the WATCHMAN® device, which has been widely studied and used for similar purposes.

Who is the study for?

Adults with non-valvular atrial fibrillation who can't take long-term oral anticoagulation but are suitable for short-term warfarin therapy. They must be at high risk of stroke, able to follow post-implant medication regimens, and willing to consent and attend follow-up visits. Exclusions include recent stroke or TIA, severe heart failure, certain allergies, pregnancy, severe renal failure, planned surgeries close to the trial period.

What is being tested?

The trial is testing the safety and effectiveness of the Amulet Left Atrial Appendage Occluder compared to the WATCHMAN device in preventing strokes in patients with atrial fibrillation. Participants will be randomly assigned one of these devices and monitored over five years.

What are the potential side effects?

Potential side effects may include discomfort or complications from device implantation like bleeding or infection; allergic reactions if sensitive to device materials; blood clots around the device leading to possible stroke; and general risks associated with catheterization procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have a type of irregular heartbeat not caused by a heart valve issue.

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I can take warfarin for a short time but not long-term oral blood thinners.

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I am at high risk for stroke or blood clots.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I had a temporary episode of atrial fibrillation.

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My kidney function is severely reduced.

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I have an active heart infection or a blood infection.

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I have symptoms from a narrowed artery in my neck.

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I need long-term blood thinners for a condition that is not atrial fibrillation.

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My heart's pumping ability is significantly reduced.

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I am prescribed a long-term P2Y12 inhibitor for my condition.

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I am at high risk for general anesthesia.

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I cannot take aspirin, clopidogrel, or warfarin due to allergies or other reasons.

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I need transfusions due to low platelet or red blood cell counts.

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I have had blood clots in my veins without a known cause, more than once.

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I have severe heart failure.

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I don't have any conditions that would prevent me from having a catheterization procedure.

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I have had a procedure to close off the left atrial appendage of my heart.

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My atrial fibrillation can be treated or reversed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 12-months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 12-months

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 12-months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Mechanism of Action Primary Endpoint: Rate of Device Closure, by the Echocardiography Core Lab (Non-inferiority Analysis)

Embolism

Hemorrhage

Secondary study objectives

Cardiovascular system

Hemorrhage

Superiority Test of Primary Effectiveness Endpoint: Composite Rate of Ischemic Stroke or Systemic Embolism

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: AmuletExperimental Treatment1 Intervention

Amulet left atrial appendage occluder

Group II: WATCHMAN (Control)Active Control1 Intervention

WATCHMAN left atrial appendage closure device

0 / 19Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for stroke prevention in patients with non-valvular atrial fibrillation, such as the Amulet™ device, involve left atrial appendage (LAA) closure. These devices work by occluding the LAA, which is a primary site for blood clot formation in AF patients. By sealing off the LAA, these devices prevent clots from entering the bloodstream and traveling to the brain, where they can cause a stroke. This mechanism is vital for stroke patients as it directly mitigates the risk of stroke by addressing the source of clot formation, offering an alternative to long-term anticoagulation therapy.