CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 97 enrolled
Drug / intervention
AMPLATZER Cardiac Plugdevice
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/NCT01118299
NCT01118299N/ACompleted
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Amplatzer Cardiac Plug Clinical Trial

Abbott Medical Devices·interventional·Posted May 6, 2010·Updated Apr 14, 2020

In Brief

A clinical study evaluating AMPLATZER Cardiac Plug for Atrial Fibrillation and 2 related conditions. Completed, enrolled 97 participants across 18 sites.

Detailed Summary

The objective of this study is to evaluate the safety and effectiveness of the ACP in subjects with nonvalvular atrial fibrillation by demonstrating that the device is non-inferior to optimal medical therapy (OMT) with respect to the primary effectiveness endpoint and superior to OMT with respect to primary safety endpoint.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAtrial Fibrillation, Ischemic Stroke, Peripheral Thromboembolism
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMay 6, 2010
Enrollment StartApr 26, 2010
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 8.6 yearsPosted 16.2 years ago

Interventions

AMPLATZER Cardiac Plugdevice

AMPLATZER Cardiac Plug is a percutaneous transcatheter device