Amulet Device for Atrial Fibrillation
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines the effectiveness of the Amulet device for individuals requiring left atrial appendage occlusion (LAAO), a procedure that helps prevent strokes in those with certain heart conditions. The study observes real-world results in the U.S. to assess the device's performance over two years. It is suitable for individuals aged 18 or older who have been recommended for LAAO with the Amulet device. Participants must agree to follow the study's testing schedule. As a Phase 4 trial, this study involves an FDA-approved device, providing participants the opportunity to contribute to understanding its benefits for more patients.
What prior data suggests that the Amulet device is safe for atrial fibrillation?
Research has shown that the Amulet device is safe for people with atrial fibrillation, a heart rhythm issue. One study found that only 2.8% of patients experienced problems over 18 months. This device is unique because it immediately seals a small pouch in the heart and eliminates the need for blood-thinning medication afterward. Clinical studies have demonstrated that it effectively reduces the risk of stroke in these patients. Overall, the Amulet device appears well-tolerated with few reported issues.12345
Why are researchers excited about this trial?
The Amulet™ ADVANCE LAA is unique because it offers a novel approach to managing atrial fibrillation by focusing on left atrial appendage (LAA) closure. Unlike standard treatments like blood thinners, which work by preventing clot formation but can increase bleeding risk, the Amulet™ device physically seals off the LAA, reducing stroke risk without relying on medication. Researchers are excited about this treatment because it provides a non-pharmacological option that could be safer for patients who cannot tolerate long-term anticoagulation therapy.
What evidence suggests that the Amulet device is effective for atrial fibrillation?
Research has shown that the Amulet device works well for people with atrial fibrillation, a heart condition. A major study found it safe and effective for five years. Another study showed that over 96% of patients using the Amulet device did not need blood thinners for three years. The device also had a low rate of major bleeding, comparable to other devices. These findings suggest that the Amulet device is a strong option for managing atrial fibrillation.678910
Who Is on the Research Team?
Dhanunjaya Lakkireddy, MD
Principal Investigator
Kansas City Cardiac Arrhythmia Research Foundation
Are You a Good Fit for This Trial?
Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Implantation of the Amplatzer™ Amulet™ Left Atrial Appendage Occluder
Initial Follow-up
First follow-up visit to assess device closure via trans-esophageal echocardiography (TEE)
Extended Follow-up
Participants are monitored for safety and effectiveness, including assessment of ischemic stroke or systemic embolism
What Are the Treatments Tested in This Trial?
Find a Clinic Near You
Who Is Running the Clinical Trial?
Abbott Medical Devices
Lead Sponsor
Dr. Etahn Korngold
Abbott Medical Devices
Chief Medical Officer
Medical training at Harvard Medical School and Massachusetts General Hospital
Robert B. Ford
Abbott Medical Devices
Chief Executive Officer since 2020
Bachelor's degree from Boston College, MBA from UC Berkeley, Haas School of Business
Citations
5-Year Results From the AMPLATZER Amulet Left Atrial ...
The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 ...
3-Year Outcomes From the Amplatzer Amulet Left Atrial ...
The Amulet occluder demonstrated continued safety and effectiveness with over 96% free of oral anticoagulation usage through 3 years in a high-risk population.
Abstract 4371051: Comparative Effectiveness and Safety of ...
Major bleeding rates were 3.0% (WATCHMAN), 2.7% (Amulet), and 2.8% (LAmbre), with WATCHMAN FLX significantly reducing bleeding vs WATCHMAN 2.5 ( ...
5-Year Results From the AMPLATZER Amulet Left Atrial ...
The 5-year outcomes from the largest randomized LAAO clinical trial demonstrated the long-term safety and effectiveness of the Amulet occluder and Watchman 2.5 ...
Amplatzer Amulet Left Atrial Appendage Occluder IDE
The Amulet IDE trial showed that the Amulet device was safe and effective at LAA occlusion. Description: The goal of the trial was to evaluate ...
Amplatzer™ Amulet™ Left Atrial Appendage Occluder
18 months (2.8%) demonstrate that the Amplatzer™ Amulet™ device is a safe and effective option for non-valvular atrial fibrillation patients at elevated ...
7.
cardiovascular.abbott
cardiovascular.abbott/us/en/hcp/products/structural-heart/structural-interventions/amplatzer-amulet.htmlAmplatzer Amulet LAA Occluder
Amulet™ is the first and only FDA-approved LAA occluder to provide an immediate and complete ostial seal without requiring OACs at discharge.1. Amplatzer Amulet ...
Safety of Amulet Left Atrial Appendage Occluder and ... - PMC
The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA Occluder and Watchman ...
9.
structuralheart.abbott
structuralheart.abbott/products/laa-closure-device/amplatzer-amulet-laa-occluder/amplatzer-amulet-laao-clinical-dataAmplatzer Amulet LAAO Clinical Data
Clinical studies have shown that implanting AFib patients with the Amplatzer Amulet occluder is a safe and effective treatment option to reduce their risk of ...
PO-671-07 SAFETY OF AMULET LAA OCCLUDER AND ...
The aim of this study was to assess and compare the safety profile peri-procedure and post-procedure between the Amplatzer Amulet LAA occluder and Watchman ...
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