Assessing Arrhythmias After Ablation Using Implantable Recorders (ABACUS)
This study is ongoing, but not recruiting participants.
Sponsor:
University of Pennsylvania
Collaborator:
Medtronic
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01176617
First received: August 4, 2010
Last updated: November 9, 2012
Last verified: June 2012
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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.
| Estimated Enrollment: | 45 |
| Study Start Date: | June 2012 |
| Estimated 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.
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|
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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.
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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
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: | November 9, 2012 |
| 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:
|
Arrhythmias, Cardiac Atrial Fibrillation Heart Diseases Cardiovascular Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on May 16, 2013