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