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Amplatzer Amulet LAAO vs. NOAC

NCT04226547 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 2650

Last updated 2026-02-10

No results posted yet for this 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

Interventions

DEVICE

Left Atrial Appendage Occlusion (Amplatzer Amulet LAA Occluder)

Implantation of an Amplatzer Amulet left atrial appendage occluder

DRUG

Non-Vitamin K Oral Antagonists

Initiation or continuation of a NOAC drug

Sponsors & Collaborators

  • Abbott Medical Devices

    lead INDUSTRY

Principal Investigators

  • Vivek Reddy, MD · Mt. Sinai Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-07
Primary Completion
2029-01-31
Completion
2031-04-30
FDA Device
Yes

Countries

  • United States
  • Australia
  • Canada
  • Czechia
  • Denmark
  • France
  • Germany
  • Hong Kong
  • Italy
  • Japan
  • Lithuania
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04226547 on ClinicalTrials.gov