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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
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Pennsylvania

August 4, 2010
August 6, 2010
April 19, 2017
April 5, 2018
April 5, 2018
June 2012
August 2012   (Final data collection date for primary outcome measure)
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.
Arrhythmia Burden [ Time Frame: 12 months ]
The primary outcome will be arrhythmia burden (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.
Complete list of historical versions of study NCT01176617 on ClinicalTrials.gov Archive Site
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.
  • 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.
  • Quality of Life Measures [ Time Frame: 12 months ]
    Quality of life measures will be achieved using the visual analog scale.
Not Provided
Not Provided
 
Assessing Arrhythmias After Ablation Using Implantable Recorders
Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy
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.
Not Provided
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Atrial Fibrillation
Device: Reveal XT implantable loop recorder
All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.
  • 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.
    Intervention: Device: Reveal XT implantable loop recorder
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
44
45
January 2013
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01176617
UPenn811675
Yes
Not Provided
Not Provided
University of Pennsylvania
University of Pennsylvania
Medtronic
Principal Investigator: Sanjay Dixit, MD University of Pennsylvania
University of Pennsylvania
April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP