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ACTIVE NOT RECRUITING

Amulet™ ADVANCE LAA

NCT05997446 · View on ClinicalTrials.gov ↗

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.

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

155 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05997446

The ClinicalTrials.gov registry entry for NCT05997446 describes a study currently listed as active not recruiting. It is categorized as an unspecified phase, 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 610 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 1 intervention — of which Left atrial appendage occlusion (LAAO) 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: NCT05997446 reports 16 study locations spanning 12 distinct geographic areas — top geographies include Florida, Kansas, Nebraska. 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 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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT05997446?

The interventions under investigation include: Left atrial appendage occlusion (LAAO) (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT05997446?

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 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.

Related

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