Clinical trial NCT00915720: Implanted Loop Recorder Post Atrial Fibrillation Ablation
Official title: Implanted Loop Recorder Surveillance of Recurrent Atrial Fibrillation After Atrial Fibrillation Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Surgical Ablation
Implanted loop recorder
Atrial Fibrillation Ablation
Lead sponsor: Thoracic & Cardiovascular Healthcare Foundation
Sponsor class: OTHER
Collaborators: name: Medtronic
name: AtriCure, Inc.
First posted: 2009-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing surgical atrial fibrillation

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

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Incidence/Duration of atrial and tachyarrhythmias post AF ablation
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lansing
country: United States
facility: Thoracic & Cardiovascular Healthcare Foundation
state: Michigan
Study officials:
affiliation: Thoracic & Cardiovascular Healthcare Foundation
name: John H Ip, MD
role: PRINCIPAL_INVESTIGATOR
References: