Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)

University of Pennsylvania

Status: Completed

Conditions: Atrial Fibrillation

Treatments: Device: Reveal XT implantable loop recorder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01176617

UPenn811675

Details and patient eligibility

About

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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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44 participants in 2 patient groups

Conventional Monitoring Strategy

No Intervention group

Description:

Subjects will be monitored for 12 months using the conventional strategy which includes wearing a monitor over 3 separate 30-day periods over the first year post-ablation and daily pulse checks.

Reveal XT

Other group

Description:

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.

Treatment:

Device: Reveal XT implantable loop recorder