Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)

This study has been completed.
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01176617
First received: August 4, 2010
Last updated: August 14, 2014
Last verified: June 2012
  Purpose

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 Intervention
Atrial Fibrillation
Device: Reveal XT implantable loop recorder

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Arrhythmia Burden [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Detection of actionable events resulting in change of clinical care [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Quality of life measures will be achieved using the visual analog scale.


Enrollment: 44
Study Start Date: June 2012
Study Completion Date: January 2013
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01176617     History of Changes
Other Study ID Numbers: UPenn811675
Study First Received: August 4, 2010
Last Updated: August 14, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on October 01, 2014