Comparison of External Event Recorders for Atrial Fibrillation Monitoring

Not Applicable

Withdrawn

• Conditions: Atrial Fibrillation
• Interventions: Device: Standard Event Monitor; Device: Sleuth Monitor

• Registration Number: NCT00863382
• Lead Sponsor: Dhanunjaya Lakkireddy, MD, FACC

Brief Summary

Ablation of atrial fibrillation is a well established treatment method to restore normal sinus rhythm and eliminate the need for continued antiarrhythmic therapy and anticoagulation. Absence of symptomatic and asymptomatic atrial fibrillation should be considered necessary for discontinuation of anticoagulation therapy. Presently, recurrence of atrial fibrillation is usually determined with the use of a non looping event monitor which is typically used by the subject at the time of symptomatic arrhythmia. This method does not detect asymptomatic atrial fibrillation. Random asymptomatic recording can be added, but the chance for detecting recurrence of arrhythmia is not great. Too frequently, the success rates of AF ablation procedures are inflated by insufficient follow up and patient's limited compliance in reporting and recording episodes of recurrent arrhythmias. Often times, it is very inconvenient for patients to wear external event recorders. Allergies to the sticky pads that are needed for most of the external monitoring devices continues to be a problem. Implantable loop recorders have the advantage of detecting symptomatic and asymptomatic atrial fibrillation continuously. They also offer the convenience of monitoring for up to 18 to 24 months without significant patient discomfort. However, implantation and explantation of these devices involves a limited surgical procedure as well as considerable experience. In this study we attempt to assess the differences in these two types of monitoring systems in assessing the long term efficacy of AF ablation.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-03-16
• Study First Submitted QC: 2009-03-17
• Study First Posted: 2009-03-18
• Primary Completion: 2011-01
• Study Completion: 2012-01
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-04
• Last Update Posted: 2012-05-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• All subjects who undergo radiofrequency ablation of paroxysmal AF.

Exclusion Criteria

• Subjects with known allergy to sticky patches of event monitor
• Subjects with skin infection or other problems on the chest that interferes with monitor implantation
• Subjects who are scheduled for radiation therapy
• Subjects who are scheduled for therapeutic ultrasound (like lithotripsy)
• Subjects who are scheduled for MRI
• Subjects who are scheduled for a procedure that uses diathermy.
• Subjects, in the opinion of the investigator, are not suitable candidates for the study
• Subjects that do not have analog telephone line at home.
• Existing Cardiac Rhythm Management Device (e.g., pacemaker or ICD)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Standard Event Monitor	Standard Event Monitor
2	Sleuth Monitor	Sleuth recorder

Primary Outcome Measures

Name	Time	Method
recurrence of atrial fibrillation	6 months, 1 year, 2 years

Secondary Outcome Measures

Name	Time	Method
cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER	6 months, 1 year, 2 years
percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control	6 months, 1 year, 2 years
percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up	6 months, 1 year, 2 years
cost differences in follow up care between the two groups	6 months, 1 year, 2 years

Trial Locations

Locations (1)

University of Kansas Medical Center; 🇺🇸 Kansas City, Kansas, United States