N/A
N=38
Assessing Arrhythmias After Ablation Using Implantable Recorders
Atrial Fibrillation
Bottom Line
View on ClinicalTrials.gov: NCT01176617 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Apr 2018
Primary outcome: Primary: Arrhythmia Burden — 7; 18; 18; 5 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Reveal XT implantable loop recorder (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Pennsylvania
- Primary completion
- Aug 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Arrhythmia Burden |
7; 18; 18; 5; 5 | — |
| SECONDARY Detection of Actionable Events Resulting in Change of Clinical Care |
0; 5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Greater than 18 years
- Undergoing ablation for atrial fibrillation at the University of Pennsylvania
Exclusion Criteria
- Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices
Data sourced from ClinicalTrials.gov (NCT01176617). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.