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NCT02879448 · ClinicalTrials.gov registry record · NA

AMPLATZER™ Amulet™ LAA Occluder Trial

A NA study, sponsored by Abbott Medical Devices.

Completed
Registry status
NA
Development phase
1,878
Enrollment target

NCT02879448: Completed NA study, sponsored by Abbott Medical Devices.

NCT02879448 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 1,878 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02879448, a NA study, has completed, sponsored by Abbott Medical Devices.

COMPLETED
Registry status
NA
Development phase
1,878 participants
Enrollment target

Study Summary

The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to receive either the Amulet device or the WATCHMAN device and will be followed for 5 years after device implant.

Primary Outcome

Procedure related complications are adverse events adjudicated by the Clinical Events Committee (CEC), as procedure related and requiring either invasive surgical or percutaneous intervention. All-cause deaths (cardiovascular or non-cardiovascular) were assessed. Major Bleeding * Type 3a: * Any transfusion with overt bleeding * Overt bleeding+Hb drop of ≥ 3 to \< 5 g/dL (provided Hb drop is related to bleed) * Type 3b: * Overt bleeding+Hb drop ≥ 5 g/dL (provided Hb drop is related to

Interventions

  • DEVICE WATCHMAN Left Atrial Appendage Closure
  • DEVICE Amulet Left Atrial Appendage Occluder

Trial Details

FieldValue
Enrollment Target 1,878 participants
Start Date 2016-08-24
Est. Completion 2024-05-24
Phase NA
Abbott Medical Devices

261 total trials

What the finished NCT02879448 record still lists

NCT02879448 is an interventional study that assigns participants to a tested intervention. Its 1,878 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (34% higher).

The record links to 0 conditions, and to 2 interventions - of which WATCHMAN Left Atrial Appendage Closure is the first listed.

NCT02879448 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02879448 about?

NCT02879448 is a clinical study titled "AMPLATZER™ Amulet™ LAA Occluder Trial". The Amulet™ device will be evaluated for safety and efficacy by demonstrating its performance is non-inferior to the commercially available WATCHMAN® left atrial appendage closure device in patients with non-valvular atrial fibrillation. Patients who are eligible for the trial will be randomized to ...

What is the current status of trial NCT02879448?

This trial is currently completed. It is a NA study. The enrollment target is 1,878 participants. The study started on 2016-08-24. Estimated completion is 2024-05-24.

What interventions are being tested in trial NCT02879448?

The interventions under investigation include: WATCHMAN Left Atrial Appendage Closure (DEVICE), Amulet Left Atrial Appendage Occluder (DEVICE).

Who is sponsoring clinical trial NCT02879448?

This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT02879448's enrollment target sits among peer trials

1,878 56th of 2000 higher than 1,945 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02879448, the US trial registry maintained by the National Library of Medicine. NCT02879448 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.