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Amplatzer Amulet LAAO vs. NOAC

Clinical Trial of Atrial Fibrillation Patients Comparing Left Atrial Appendage Occlusion Therapy to Non-vitamin K Antagonist Oral Anticoagulants

NCT04226547•Abbott Medical Devices

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Documented paroxysmal, persistent, or permanent non-valvular AF (documentation must include an electrocardiogram, Holter, or event recorder)
•At high risk of stroke or systemic embolism, defined as a CHA2DS2-VASc score of ≥ 2 for men and ≥ 3 for women
•Eligible for long-term NOAC therapy
•Able to comply with the required NOAC medication regimen if randomized to the Control Group
•Able to comply with the required medication regimen post-device implant if subject is randomized to the Device Group or subject is a Roll-in
•Able to understand, and is willing to provide, written informed consent to participate in the trial, prior to any clinical investigation related procedure or assessment
•18 years of age or older, or the age of legal consent
•Able and willing to return for required follow-up visits and assessments
•Has known intracranial atherosclerosis and/or intracranial small vessel disease (defined as 6 points on the Fazekas Scale)
•Reversible cause of AF (i.e., secondary to thyroid disorders, acute alcohol intoxication, trauma, recent major surgical procedures)
+11 more criteria

Exclusion Criteria

•Requires long-term OAC therapy for a condition other than AF
•Planned cardiac intervention or surgery, which is invasive or requires sedation or anesthesia, within 3 months following randomization, other than study-related procedures such as LAAO and cardiac imaging (if applicable)
•Known contraindication to, or allergic to, aspirin, clopidogrel, or OAC medication use
•Indicated for P2Y12 platelet inhibitor for \>1 year post-randomization
•In the opinion of the investigator, is considered at high risk for general anesthesia and general anesthesia is planned for the study procedure
•Has undergone atrial septal defect (ASD) repair or has an ASD closure device present
•Has undergone patent foramen ovale (PFO) repair or has a PFO closure device implanted
•Is implanted with a mechanical valve prosthesis
•Is implanted with an inferior vena cava filter
•History of rheumatic or congenital mitral valve heart disease
+8 more criteria

Locations (127)

University Hospital - Univ. of Alabama at Birmingham (UAB)

Birmingham, Alabama, United States

Heart Center Research, LLC

Huntsville, Alabama, United States

Arizona Cardiovascular Research Center

Phoenix, Arizona, United States

Tucson Medical Center

Tucson, Arizona, United States

Arrhythmia Research Group

Jonesboro, Arkansas, United States

UAMS Medical Center

Little Rock, Arkansas, United States

Scripps Health

La Jolla, California, United States

Kaiser Permanente Los Angeles Medical Center

Los Angeles, California, United States

Huntington Memorial Hospital

Pasadena, California, United States

Mercy Medical Group - Cardiology

Sacramento, California, United States

Key Dates

Start Date

July 7, 2020

Primary Completion Date

January 1, 2029

Completion Date

April 1, 2031

Last Updated

February 10, 2026

Enrollment

2,650

ESTIMATED participants

Conditions

Atrial FibrillationStrokeBleeding

Interventions

Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)

DEVICE

Non-Vitamin K Oral Antagonists

DRUG

Cerebellar Stimulation for Aphasia Rehabilitation

NCT05093673

Stroke

View study

RECRUITINGPHASE1

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of LWP779 in Healthy Participants

NCT07371455

Ischemic Stroke

View study

RECRUITINGNA

Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 10, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Amplatzer Amulet LAAO vs. NOAC

Inclusion Criteria

Exclusion Criteria

Cerebellar Stimulation for Aphasia Rehabilitation

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Effects of Circuit Training Combining Different Types of Distal Robot-assisted and Task-oriented Therapy on Motor Control, Motor and Daily Functions, and Quality of Life After Stroke

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