Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Amplatzer Amulet LAAO vs. NOAC
NCT04226547 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04226547
The ClinicalTrials.gov registry entry for NCT04226547 describes a study currently listed as active not recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 2,650 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Abbott Medical Devices, which has 155 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04226547 reports 20 study locations spanning 7 distinct geographic areas — top geographies include Florida, California, Alabama. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04226547?
This trial is sponsored by Abbott Medical Devices, which has 155 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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.
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