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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

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 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

Resource links provided by the National Library of Medicine


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.




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.



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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

Information from the National Library of Medicine

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


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

Publications of Results:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01176617     History of Changes
Other Study ID Numbers: UPenn811675
First Posted: August 6, 2010    Key Record Dates
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