Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)
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|ClinicalTrials.gov Identifier: NCT01176617|
Recruitment Status : Completed
First Posted : August 6, 2010
Results First Posted : April 5, 2018
Last Update Posted : April 5, 2018
|Condition or disease||Intervention/treatment||Phase|
|Atrial Fibrillation||Device: Reveal XT implantable loop recorder||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||August 2012|
|Actual Study Completion Date :||January 2013|
No Intervention: Conventional Monitoring Strategy
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.
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.
Device: Reveal XT implantable loop recorder
All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
- 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.
- Detection of Actionable Events Resulting in Change of Clinical Care [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01176617
|United States, Pennsylvania|
|University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19014|
|Principal Investigator:||Sanjay Dixit, MD||University of Pennsylvania|