Assessing Arrhythmias After Ablation Using Implantable Recorders

University of Pennsylvania44 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Atrial Fibrillation

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

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.

Time frame: 6 and 12 months

Secondary Outcomes

Detection of Actionable Events Resulting in Change of Clinical Care

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.

Time frame: 12 months