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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 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.

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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.

Conditions Studied

Stroke Atrial Fibrillation Bleeding

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

FieldValue
Enrollment Target 610 participants
Start Date 2023-07-12
Est. Completion 2027-06

Sponsor

Abbott Medical Devices

261 total trials

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What the Registry Record Tells You About NCT05997446

The ClinicalTrials.gov registry entry for NCT05997446 describes a study currently listed as active not recruiting, categorized as an unspecified phase. The registered enrollment target is 610 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 12,015-participant average among 454 other Stroke trials with a reported enrollment target (95% lower). The listed sponsor is Abbott Medical Devices, which has 261 total studies on file at ClinicalTrials.gov.

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 reports 16 study locations spanning 12 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.