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Implanted Loop Recorder Post Atrial Fibrillation Ablation

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: NCT00915720
Recruitment Status : Unknown
Verified July 2010 by Thoracic & Cardiovascular Healthcare Foundation.
Recruitment status was:  Active, not recruiting
First Posted : June 8, 2009
Last Update Posted : July 20, 2011
Information provided by:

June 4, 2009
June 8, 2009
July 20, 2011
August 2008
December 2011   (Final data collection date for primary outcome measure)
Incidence/Duration of atrial and tachyarrhythmias post AF ablation [ Time Frame: 14 months ]
Same as current
Complete list of historical versions of study NCT00915720 on ClinicalTrials.gov Archive Site
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Implanted Loop Recorder Post Atrial Fibrillation Ablation
Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation
This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.

Atrial Fibrillation (AF)is the most common arrhythmia and causes significant morbidity and mortality. Treatment for AF consists of medical therapy and ablation therapy. Medical therapies can help approximately 50% of patients, the rest must resort to ablation procedures.

Ablation procedures aim to isolate the pulmonary vein from the atrial tissue electrically and can be performed either endocardially through catheters inserted through the femoral veins or epicardially through a minimal lateral thoracotomy. Both procedures are accepted as standard of care.

Recurrent AF after ablation therapy can be common and occurs in 50% of patients and could be in a form of short periods of AF or persistent AF with less or minimal symptoms. This is of significant clinical relevance as most of these AF episodes are not recognized and can lead to thromboembolic events such as stroke. However, techniques of surveillance of AF post ablation have been suboptimal. Physicians could use holter monitoring but this is limited to a short period of 24 - 48 hours. Event recorders which are external can be used but patients need to experience symptoms associated with the AF episodes in order to record the episodes.

Better AF monitoring techniques especially after AF ablation are necessary so that recognition of AF recurrence in these patient could be possible and timely anticoagulation therapy initiated may prevent strokes.

This pilot study involves implanting a loop recorder just under the skin to record cardiac rhythms 24 hours per day without any interaction by the patient. These devices are currently approved by the FDA for monitoring of syncope and will be implanted during the patients AF ablation surgery.

Observational Model: Case-Only
Time Perspective: Prospective
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Non-Probability Sample
Patients undergoing surgical atrial fibrillation
Atrial Fibrillation
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Unknown status
December 2012
December 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing surgical atrial fibrillation ablation
  • Patients must be 18 years or older

Exclusion Criteria:

  • Patients unwilling to comply with the follow up schedule
  • Pregnant or breastfeeding patients
  • Patients currently participating in another study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
ILR 1208
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John H. Ip, MD FACC, Thoracic & Cardiovascular Healthcare Foundation
Thoracic & Cardiovascular Healthcare Foundation
  • Medtronic
  • AtriCure, Inc.
Principal Investigator: John H Ip, MD Thoracic & Cardiovascular Healthcare Foundation
Thoracic & Cardiovascular Healthcare Foundation
July 2010