Assessing Arrhythmias After Ablation Using Implantable Recorders

NCT01176617 | Completed Results DMC

• 1 other identifier: UPenn811675
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Atrial Fibrillation

Keywords

Atrial Fibrillation; A-Fib; AF; Persistent; Permanent; Pulmonary Vein isolation; Ablation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Detection of Actionable Events Resulting in Change of Clinical Care

  12 months

Study Arms (2)

Conventional Monitoring Strategy

NO INTERVENTION

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

OTHER

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

Interventions

Reveal XT implantable loop recorder DEVICE

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

Reveal XT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Greater than 18 years
• Undergoing ablation for atrial fibrillation at the University of Pennsylvania

You may not qualify if:

• Patients with already implanted devices, including pacemakers, implantable cardiac defibrillators and cardiac resynchronization devices

Sponsors & Collaborators

• University of Pennsylvania: lead
• Medtronic: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19014, United States

Location

Related 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 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.

  PMID: 23577826 RESULT

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Sanjay Dixit
• Organization: Hospital of the University of Pennsylvania

sanjay.dixit@uphs.upenn.edu

215-615-4337

Study Officials

• Sanjay Dixit, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2010
• First Posted: August 6, 2010
• Study Start: June 1, 2012
• Primary Completion: August 1, 2012
• Study Completion: January 1, 2013
• Last Updated: April 5, 2018
• Results First Posted: April 5, 2018

Record last verified: 2018-04

Locations

US (1)