Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)

• ClinicalTrials.gov Identifier: NCT01176617
• Recruitment Status: Completed
• First Posted: August 6, 2010
• Results First Posted: April 5, 2018
• Last Update Posted: April 5, 2018
• Sponsor: University of Pennsylvania
• Collaborator: Medtronic
• Information provided by (Responsible Party): University of Pennsylvania

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Atrial Fibrillation	Device: Reveal XT implantable loop recorder	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 44 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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

Arms and Interventions

Arm	Intervention/treatment
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.
Reveal XT; 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.

Outcome Measures

Primary Outcome Measures :

1. 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 Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Pennsylvania

University of Pennsylvania

Philadelphia, Pennsylvania, United States, 19014

Sponsors and Collaborators

University of Pennsylvania

Medtronic

Investigators

• Principal Investigator: Sanjay Dixit, MD; University of Pennsylvania

More Information

Publications of Results:

Kapa S, Epstein AE, Callans DJ, Garcia FC, Lin D, Bala R, Riley MP, Hutchinson MD, Gerstenfeld EP, Tzou W, Marchlinski FE, Frankel DS, Cooper JM, Supple G, Deo R, Verdino RJ, Patel VV, Dixit S. Assessing arrhythmia burden after catheter ablation of atrial fibrillation using an implantable loop recorder: the ABACUS study. J Cardiovasc Electrophysiol. 2013 Aug;24(8):875-81. doi: 10.1111/jce.12141. Epub 2013 Apr 11.

• Responsible Party: University of Pennsylvania
• ClinicalTrials.gov Identifier: NCT01176617
• Other Study ID Numbers: UPenn811675
• First Posted: August 6, 2010
• Results First Posted: April 5, 2018
• Last Update Posted: April 5, 2018
• Last Verified: April 2018

Keywords provided by University of Pennsylvania:

Atrial Fibrillation; A-Fib; AF; Persistent; Permanent; Pulmonary Vein isolation; Ablation

Additional relevant MeSH terms:

Atrial Fibrillation; Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes