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Comparison of External Event Recorders for Atrial Fibrillation Monitoring

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00863382
Recruitment Status : Withdrawn
First Posted : March 18, 2009
Last Update Posted : May 7, 2012
Sponsor:
Information provided by (Responsible Party):
Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center

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.

Condition or disease Intervention/treatment Phase
Atrial Fibrillation Device: Standard Event Monitor Device: Sleuth Monitor Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparison of External Event Recorders With Implantable Monitor for Post Atrial Fibrillation Monitoring: Assessment of Cost and Efficacy
Study Start Date : January 2009
Estimated Primary Completion Date : January 2011
Estimated Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 1
Standard Event Monitor
Device: Standard Event Monitor
Standard Event Monitor

Active Comparator: 2
Sleuth recorder
Device: Sleuth Monitor
Implantable Sleuth Recorder




Primary Outcome Measures :
  1. recurrence of atrial fibrillation [ Time Frame: 6 months, 1 year, 2 years ]

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00863382


Locations
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United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Sponsors and Collaborators
Dhanunjaya Lakkireddy, MD, FACC
Investigators
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Principal Investigator: Dhanunjuya Lakkireddy, MD University of Kansas Medical Center
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Responsible Party: Dhanunjaya Lakkireddy, MD, FACC, Associate Professor of Medicine, University of Kansas Medical Center
ClinicalTrials.gov Identifier: NCT00863382    
Other Study ID Numbers: 11566
First Posted: March 18, 2009    Key Record Dates
Last Update Posted: May 7, 2012
Last Verified: May 2012
Keywords provided by Dhanunjaya Lakkireddy, MD, FACC, University of Kansas Medical Center:
atrial fibrillation
Additional relevant MeSH terms:
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Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes