Overview

This trial is active, not recruiting.

Condition atrial fibrillation
Sponsor Thoracic & Cardiovascular Healthcare Foundation
Collaborator Medtronic
Start date August 2008
End date December 2011
Trial size 50 participants
Trial identifier NCT00915720, ILR 1208

Summary

This is a pilot study to determine if implanted loop recorders can more effectively monitor atrial fibrillation recurrence after atrial fibrillation ablation.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
Incidence/Duration of atrial and tachyarrhythmias post AF ablation
time frame: 14 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation
Principal investigator John H Ip, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2011.
Information provided to ClinicalTrials.gov by Thoracic & Cardiovascular Healthcare Foundation.