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NCT01176617 · ClinicalTrials.gov registry record · NA
Assessing Arrhythmias After Ablation Using Implantable Recorders
A NA study, sponsored by University of Pennsylvania.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT01176617: Completed NA study, sponsored by University of Pennsylvania.
NCT01176617 is a NA study that has completed, run by University of Pennsylvania. The registered enrollment target is 44 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01176617, a NA study, has completed, sponsored by University of Pennsylvania.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current conventional monitoring strategy used by us for determination of atrial fibrillation recurrence (ie. return of the abnormal heart rhythm) and/or arrythmia burden (ie. how long the abnormal rhythm continues or how often the rhythm occurs). Some data suggests that continuous monitoring over longer periods may be better in identifying recurrence of atrial fibrillation after ablation and thus assist in its overall management. The device being used for this study is the Reveal XT, which, is currently FDA approved for monitoring all varieties of cardiac rhythm disorders including atrial fibrillation.
Primary Outcome
The primary outcome will be arrhythmia recurrences (atrial fibrillation and/or other atrial arrhythmias) after atrial fibrillation ablation over the initial 6 months and one year post-ablation as detected by the implantable loop recorder versus the conventional monitoring strategy. Months 1- 6 patients were being monitored by CM and ILR and in months 6 - 12 they were randomized to either ILR or CM.
Interventions
- DEVICE Reveal XT implantable loop recorder
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-01 |
| Phase | NA |
What the finished NCT01176617 record still lists
NCT01176617 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 1 intervention - of which Reveal XT implantable loop recorder is the first listed.
NCT01176617 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01176617 about?
NCT01176617 is a clinical study titled "Assessing Arrhythmias After Ablation Using Implantable Recorders". The purpose of this study is to determine if continuous monitoring using an implantable loop recorder (ie. a device that is placed just underneath the skin of the chest and monitors the heart rate and rhythm) for a year long period after atrial fibrillation ablation may be superior to the current co...
What is the current status of trial NCT01176617?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2012-06. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01176617?
The interventions under investigation include: Reveal XT implantable loop recorder (DEVICE).
Who is sponsoring clinical trial NCT01176617?
This trial is sponsored by University of Pennsylvania, which has 1,423 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01176617's enrollment target sits among peer trials
44 1423rd of 2000 higher than 566 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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