Assessing Arrhythmias After Ablation Using Implantable Recorders

Atrial Fibrillation Clinical Trial

— ABACUS  

Official title:

Assessment of Arrhythmia Burden in Patients Undergoing Atrial Fibrillation Using an Implantable Loop Recorder (ILR) Versus Conventional Monitoring Strategy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01176617
• Other study ID #: UPenn811675
• Status: Completed
• Phase: N/A
• First received: August 4, 2010
• Last updated: April 3, 2018
• Start date: June 2012
• Est. completion date: January 2013

Study information

• Verified date: April 2018
• Source: University of Pennsylvania
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: January 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Reveal XT implantable loop recorder
All study participants will receive the Reveal XT implantable loop recorder immediately after completion of the ablation procedure.

Locations

Country	Name	City	State
United States	University of Pennsylvania	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pennsylvania	Medtronic

Country where clinical trial is conducted

United States, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arrhythmia Burden	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.	6 and 12 months
Secondary	Detection of Actionable Events Resulting in Change of Clinical Care	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.	12 months