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Clinical Trials/NCT01176617
NCT01176617
Completed
N/A

Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy

University of Pennsylvania1 site in 1 country44 target enrollmentJune 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Atrial Fibrillation
Sponsor
University of Pennsylvania
Enrollment
44
Locations
1
Primary Endpoint
Arrhythmia Burden
Status
Completed
Last Updated
8 years ago

Overview

Brief 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.

Registry
clinicaltrials.gov
Start Date
June 2012
End Date
January 2013
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Arrhythmia Burden

Time Frame: 6 and 12 months

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.

Secondary Outcomes

  • Detection of Actionable Events Resulting in Change of Clinical Care(12 months)

Study Sites (1)

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