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NCT01118299 · ClinicalTrials.gov registry record · NA
AMPLATZER Cardiac Plug Clinical Trial
A NA study, sponsored by Abbott Medical Devices.
- Completed
- Registry status
- NA
- Development phase
- 97
- Enrollment target
NCT01118299: Completed NA study, sponsored by Abbott Medical Devices.
NCT01118299 is a NA study that has completed, run by Abbott Medical Devices. The registered enrollment target is 97 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01118299, a NA study, has completed, sponsored by Abbott Medical Devices.
- COMPLETED
- Registry status
- NA
- Development phase
- 97 participants
- Enrollment target
Study 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.
Primary Outcome
An analysis comparing the rate of procedure related serious adverse events that occur in the device arm to a performance goal determined from literature reported rates for similar procedural techniques. The study as designed was intended to determine the difference in efficacy and safety between the device and control arm (subjects treated with OMT). However, due to early enrollment closure, the three primary endpoints were not analyzed as specified in the original trial protocol. As the Contr
Interventions
- DEVICE AMPLATZER Cardiac Plug
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2010-04-26 |
| Est. Completion | 2018-12-06 |
| Phase | NA |
What the finished NCT01118299 record still lists
NCT01118299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).
The record links to 0 conditions, and to 1 intervention - of which AMPLATZER Cardiac Plug is the first listed.
NCT01118299 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01118299 about?
NCT01118299 is a clinical study titled "AMPLATZER Cardiac Plug Clinical Trial". 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...
What is the current status of trial NCT01118299?
This trial is currently completed. It is a NA study. The enrollment target is 97 participants. The study started on 2010-04-26. Estimated completion is 2018-12-06.
What interventions are being tested in trial NCT01118299?
The interventions under investigation include: AMPLATZER Cardiac Plug (DEVICE).
Who is sponsoring clinical trial NCT01118299?
This trial is sponsored by Abbott Medical Devices, which has 261 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01118299's enrollment target sits among peer trials
97 923rd of 2000 higher than 1,076 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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