Assessing Arrhythmias After Ablation Using Implantable Recorders

Not Applicable

Completed

• Conditions: Atrial Fibrillation
• Interventions: Device: Reveal XT implantable loop recorder

• Registration Number: NCT01176617
• Lead Sponsor: University of Pennsylvania

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-08-04
• Study First Submitted QC: 2010-08-04
• Study First Posted: 2010-08-06
• Study Start: 2012-06
• Primary Completion: 2012-08
• Study Completion: 2013-01
• Results First Submitted: 2017-04-19
• Status Verified: 2018-04
• Results First Submitted QC: 2018-04-03
• Last Update Submitted: 2018-04-03
• Results First Posted: 2018-04-05
• Last Update Posted: 2018-04-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 44

Inclusion Criteria

• Greater than 18 years
• Undergoing ablation for atrial fibrillation at the University of Pennsylvania

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Exclusion Criteria

• Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Reveal XT	Reveal XT implantable loop recorder	Subjects will be monitored using the conventional monitoring strategy for the first 6 months post-ablation. During the next 6 months, subjects will be monitored using the data from the Reveal device, transmitted from home every 30 days.

Primary Outcome Measures

Name	Time	Method
Arrhythmia Burden	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 Outcome Measures

Name	Time	Method
Detection of Actionable Events Resulting in Change of Clinical Care	12 months	Change of clinical care include initiation of previously discontinued and/or new anti-arrhythmic drugs, decision for repeat ablation, hospitalization for arrhythmias, discontinuation or reinitiation of atrio-ventricular nodal blocking agents, discontinuation or reinitiation af anticoagulation after ablation and/or decision to implant a pacemaker and/or defibrillator.

Trial Locations

Locations (1)

University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States