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NCT01727297 · ClinicalTrials.gov registry record · NA
REVEAL AF: Incidence of AF in High Risk Patients
A NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- Completed
- Registry status
- NA
- Development phase
- 446
- Enrollment target
NCT01727297: Completed NA study, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
NCT01727297 is a NA study that has completed, run by Medtronic Cardiac Rhythm and Heart Failure. The registered enrollment target is 446 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01727297, a NA study, has completed, sponsored by Medtronic Cardiac Rhythm and Heart Failure.
- COMPLETED
- Registry status
- NA
- Development phase
- 446 participants
- Enrollment target
Study Summary
This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study will also seek to identify what patient characteristics are most predictive of developing AF.
Primary Outcome
Incidence of adjudicated AF lasting six or more minutes at 18 months. Each arrhythmic episode detected by the patient's Reveal device will be reviewed to determine if it is 1) an actual atrial fibrillation episode, and (2) is at least 6 minutes in duration. The first such episode per patient occurring within 18 months will be utilized to determine the 18 month incidence rate.
Interventions
- DEVICE REVEAL Implantable Cardiac Monitor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 446 participants |
| Start Date | 2012-11-13 |
| Est. Completion | 2017-01-30 |
| Phase | NA |
What the finished NCT01727297 record still lists
NCT01727297 is an interventional study that assigns participants to a tested intervention. The registered 446 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (68% lower).
The record links to 0 conditions, and to 1 intervention - of which REVEAL Implantable Cardiac Monitor is the first listed.
NCT01727297 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01727297 about?
NCT01727297 is a clinical study titled "REVEAL AF: Incidence of AF in High Risk Patients". This study is to determine, through continuous monitoring with the Reveal implantable cardiac monitor (ICM), the incidence of atrial fibrillation (AF) in patients suspected to be at high risk for having AF and to understand how physicians manage these patients after AF has been detected. This study ...
What is the current status of trial NCT01727297?
This trial is currently completed. It is a NA study. The enrollment target is 446 participants. The study started on 2012-11-13. Estimated completion is 2017-01-30.
What interventions are being tested in trial NCT01727297?
The interventions under investigation include: REVEAL Implantable Cardiac Monitor (DEVICE).
Who is sponsoring clinical trial NCT01727297?
This trial is sponsored by Medtronic Cardiac Rhythm and Heart Failure, which has 115 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01727297's enrollment target sits among peer trials
446 233rd of 2000 higher than 1,768 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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