Comparison of External Event Recorders for Atrial Fibrillation Monitoring

Atrial Fibrillation Clinical Trial

Official title:

Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00863382
• Other study ID #: 11566
• Status: Withdrawn
• Phase: N/A
• First received: March 16, 2009
• Last updated: May 4, 2012
• Start date: January 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2012
• Source: University of Kansas Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Fibrillation

Intervention

Device:
• Standard Event Monitor
Standard Event Monitor
• Sleuth Monitor
Implantable Sleuth Recorder

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Dhanunjaya Lakkireddy, MD, FACC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recurrence of atrial fibrillation		6 months, 1 year, 2 years	Yes
Secondary	cost-effectiveness ratio (ICER) between the two technologies and the 95% confidence interval for the ICER		6 months, 1 year, 2 years	No
Secondary	percentage of patients whose Coumadin is stopped prematurely due to inappropriate assumption of rhythm control		6 months, 1 year, 2 years	Yes
Secondary	percentage of patients who develop symptoms of stroke or transient ischemic attacks during follow up		6 months, 1 year, 2 years	No
Secondary	cost differences in follow up care between the two groups		6 months, 1 year, 2 years	No