Implanted Loop Recorder Post Atrial Fibrillation Ablation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2010 by Thoracic & Cardiovascular Healthcare Foundation.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborators:
Medtronic
AtriCure, Inc.
Information provided by:
Thoracic & Cardiovascular Healthcare Foundation
ClinicalTrials.gov Identifier:
NCT00915720
First received: June 4, 2009
Last updated: July 19, 2011
Last verified: July 2010

June 4, 2009
July 19, 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 ] [ Designated as safety issue: No ]
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
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.
 
Active, not recruiting
50
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00915720
ILR 1208
No
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

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP