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Amulet™ ADVANCE LAA
N/A
Waitlist Available
Led By Dhanunjaya Lakkireddy, MD
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through 24 months
Awards & highlights
No Placebo-Only Group
Summary
This is a prospective, multicenter, observational study intended to characterize real-world outcomes on the commercially available Amulet device in the United States. Over 600 subjects have been enrolled at 16 US clinical sites. Subjects will be followed through 24 months in accordance with each site's standard care practices.
Eligible Conditions
- Atrial Fibrillation
- Stroke
- Hemorrhage
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through 24 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through 24 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Composite endpoint: Death or complications
Composite endpoint: Ischemic stroke or systemic embolism
Device closure, defined as residual jet around the device ≤ 3mm
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Find a Location
Who is running the clinical trial?
Abbott Medical DevicesLead Sponsor
652 Previous Clinical Trials
416,227 Total Patients Enrolled
77 Trials studying Atrial Fibrillation
31,905 Patients Enrolled for Atrial Fibrillation
Dhanunjaya Lakkireddy, MDPrincipal InvestigatorKansas City Cardiac Arrhythmia Research Foundation
29 Previous Clinical Trials
9,050 Total Patients Enrolled
15 Trials studying Atrial Fibrillation
4,702 Patients Enrolled for Atrial Fibrillation