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NCT04226547 · ClinicalTrials.gov registry record · NA
Amplatzer Amulet LAAO vs. NOAC
A NA study of Stroke and Atrial Fibrillation, sponsored by Abbott Medical Devices.
- Active
- Registry status
- NA
- Development phase
- 2,650
- Enrollment target
- 20
- Study locations
NCT04226547: Active NA study of Stroke and Atrial Fibrillation, sponsored by Abbott Medical Devices.
NCT04226547 is a NA study of Stroke and Atrial Fibrillation that is active but no longer recruiting, run by Abbott Medical Devices. The registered enrollment target is 2,650 participants, below the 12,011-participant average among 454 other Stroke trials with a reported enrollment target (78% lower). The trial reports 20 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04226547, a NA study of Stroke and Atrial Fibrillation, is active but no longer recruiting, sponsored by Abbott Medical Devices.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 2,650 participants
- Enrollment target
- 20
- Study locations
Study Summary
The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomized, multicenter active control worldwide trial. Subjects will be randomized in a 1:1 ratio between the Amulet LAA occlusion device ("Device Group") and a commercially available NOAC medication ("Control Group"). The choice of NOAC in the Control Group will be left to study physician discretion.
Primary Outcome
non-inferiority
Conditions Studied
Interventions
- DEVICE Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)
- DRUG Non-Vitamin K Oral Antagonists
Study Locations (20)
Florida
- AdventHealth Florida Cardiology - Altamonte Springs - Altamonte Springs
- St. Vincent's Medical Center - Jacksonville
- Baptist Medical Center - Jacksonville
- AdventHealth Florida Cardiology - Lake Mary - Lake Mary
- NCH Healthcare System - Naples
- AdventHealth Orlando - Orlando
- AdventHealth Florida Cardiology - Oviedo - Oviedo
- Sarasota Memorial Hospital - Sarasota
California
- Scripps Health - La Jolla
- Kaiser Permanente Los Angeles Medical Center - Los Angeles
- Huntington Memorial Hospital - Pasadena
- Mercy Medical Group - Cardiology - Sacramento
Alabama
- University Hospital - Univ. of Alabama at Birmingham (UAB) - Birmingham
- Heart Center Research, LLC - Huntsville
Arizona
- Arizona Cardiovascular Research Center - Phoenix
- Tucson Medical Center - Tucson
Arkansas
- Arrhythmia Research Group - Jonesboro
- UAMS Medical Center - Little Rock
Colorado
- South Denver Cardiology Associates PC - Littleton
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,650 participants |
| Start Date | 2020-07-07 |
| Est. Completion | 2031-04 |
| Phase | NA |
What the registry record for NCT04226547 still lists
NCT04226547 is an interventional study that assigns participants to a tested intervention. Its 2,650 participants enrollment target places it among the larger protocols in the corpus, below the 12,011-participant average among 454 other Stroke trials with a reported enrollment target (78% lower).
The record links to 3 conditions, with Stroke appearing as the primary indexed condition, and to 2 interventions - of which Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) is the first listed.
NCT04226547 names 20 study sites across 7 states, led by Florida, California, Alabama.
Frequently Asked Questions
What is clinical trial NCT04226547 about?
NCT04226547 is a clinical study titled "Amplatzer Amulet LAAO vs. NOAC". The objective of this trial is to evaluate the safety and effectiveness of the Amulet LAA occluder compared to NOAC therapy in patients with non-valvular AF at increased risk for ischemic stroke and who are recommended for long-term NOAC therapy. The clinical investigation is a prospective, randomi...
What is the current status of trial NCT04226547?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 2,650 participants. The study started on 2020-07-07. Estimated completion is 2031-04.
What conditions does trial NCT04226547 study?
This clinical trial studies the following conditions: Stroke, Atrial Fibrillation, Bleeding.
What interventions are being tested in trial NCT04226547?
The interventions under investigation include: Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder) (DEVICE), Non-Vitamin K Oral Antagonists (DRUG).
Who is sponsoring clinical trial NCT04226547?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04226547 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04226547's enrollment target sits among peer trials
2,650 24th of 454 higher than 431 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.
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