CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,088 enrolled
Drug / intervention
Subjects implanted with Amulet Devicedevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02447081
NCT02447081N/ACompleted
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Amplatzer™Amulet™ Observational Post-Market Study

Abbott Medical Devices·observational·Posted May 18, 2015·Updated Dec 30, 2019

In Brief

An observational study evaluating Subjects implanted with Amulet Device for Atrial Fibrillation and 2 related conditions. Completed, enrolled 1,088 participants across 51 sites in 16 countries.

Detailed Summary

This was a prospective, multicenter, observational, nonrandomized study to compile real world outcome data on the use of the Amulet™ device in non-valvular atrial fibrillation (NVAF) subjects. The study was designed to follow the Instructions For Use (IFU) to gather data on the implant procedure through two years of follow up with the Amulet™ device in a commercial clinical setting."

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Thromboembolism, Stroke
CountriesAustralia, Belgium, Chile, Denmark, Finland, France, Germany, Ireland, Israel, Italy, Netherlands, Norway, Poland, Spain, Sweden, United Kingdom
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 18, 2015
Enrollment StartJun 1, 2015
Primary CompletionOct 23, 2018
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 11.1 years ago

Interventions

Subjects implanted with Amulet Devicedevice

Percutaneous Left Atrial Appendage occlusion with successful implant of occlusion device.