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NCT05997446 · ClinicalTrials.gov registry record
Amulet™ ADVANCE LAA
A clinical trial of Stroke and Atrial Fibrillation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- 610
- Enrollment target
- 16
- Study locations
NCT05997446: Active study of Stroke and Atrial Fibrillation, sponsored by Abbott Medical Devices.
NCT05997446 is a study of Stroke and Atrial Fibrillation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 610 participants, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower). The trial reports 16 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05997446, a study of Stroke and Atrial Fibrillation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- 610 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
Composite of all-cause death, ischemic stroke, systemic embolism, or device/procedure related complications requiring an invasive surgical or percutaneous intervention within 7 days of implant or hospital discharge, whichever is later
Conditions Studied
Interventions
- DEVICE Left atrial appendage occlusion (LAAO)
Study Locations (16)
Florida
- Baptist Medical Center - Jacksonville
- Usman R. Siddiqui, MD - Winter Park
Kansas
- Kansas City Cardiac Arrhythmia Research Foundation - Overland Park
- Cardiovascular Research Institute of Kansas - Wichita
Nebraska
- Bryan Heart - Lincoln
- CHI Health Creighton University Medical Center-Bergan Mercy - Omaha
Texas
- Baylor All Saints Medical Center at Fort Worth - Fort Worth
- Heart Rhythm Associates - Shenandoah
Arizona
- Arizona Arrhythmia Research - Phoenix
Arkansas
- Arkansas Heart Hospital - Little Rock
Illinois
- PERC - O'Fallon - O'Fallon
Michigan
- Providence Hospital - Southfield
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 610 participants |
| Start Date | 2023-07-12 |
| Est. Completion | 2027-06 |
What the registry record for NCT05997446 still lists
NCT05997446 is an observational study that tracks outcomes without assigning an intervention. The registered 610 participants enrollment target is mid-sized for trials with a published cap, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower).
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 1 intervention - of which Left atrial appendage occlusion (LAAO) is the first listed.
NCT05997446 lists 16 locations in 12 states (Florida, Kansas, Nebraska).
Frequently Asked Questions
What is clinical trial NCT05997446 about?
NCT05997446 is a clinical study titled "Amulet™ ADVANCE LAA". 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 sit...
What is the current status of trial NCT05997446?
This trial is currently active not recruiting. The enrollment target is 610 participants. The study started on 2023-07-12. Estimated completion is 2027-06.
What conditions does trial NCT05997446 study?
This clinical trial studies the following conditions: Stroke, Atrial Fibrillation, Bleeding.
What interventions are being tested in trial NCT05997446?
The interventions under investigation include: Left atrial appendage occlusion (LAAO) (DEVICE).
Who is sponsoring clinical trial NCT05997446?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05997446 being conducted?
This trial has 16 study locations across Arizona, Arkansas, Florida, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stroke
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05997446's enrollment target sits among peer trials
610 49th of 454 higher than 406 of 454 other Stroke trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stroke trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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