An isolation-limited segmental antral approach to pulmonary vein isolation is as effective in achieving long-term freedom from atrial fibrillation as the standard anatomic, circumferential antral ablation.
This is a randomized controlled non-inferiority designed trial. Follow up: Patients will stop their anti-arrhythmic drugs 2 months post procedure. Follow-ups will involve clinical assessment, holter and/or loop recorders at 3, 6, 9, and 12 month intervals.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
120
The goal is to complete ablation in all segments around the pulmonary veins until a circle of ablation lesions is created in the antrum with at least 30 seconds of ablation, 25W on the posterior surface, 30W on the anterior surface at each site, and change in the local electrogram. Entry and Exit block will be confirmed in each vein. The left superior pulmonary vein and left inferior pulmonary vein will be isolated with one circle, and the right superior and right inferior pulmonary veins will be isolated with one circle.
If the patient is in atrial fibrillation, ablation will begin in the segment with the highest frequency signals in the pulmonary vein antrum. If the patient is in sinus rhythm, mapping and ablation will occur during coronary sinus pacing. Segments with the earliest signals in the Lasso catheter will be targeted, and reassessed after each ablation lesion. This will continue in a segmental fashion on the antrum until pulmonary vein isolation is achieved. Lasso should be moved between veins between lesions to assess the earliest electrogram. Entry and exit block will be confirmed at each vein.
London Health Science Centre
London, Ontario, Canada
Freedom from atrial fibrillation
Symptomatic atrial fibrillation recurrence (without anti-arrhythmic med's)
Time frame: six months
Procedure time
How long did the procedure take?
Time frame: (4-6) hours From the time patient is draped to the time electrophysiology catheters are removed from the body (same day in the electrophysiology lab)
Ablation Time
A cumulative measurement of the duration of ablation used during the pulmonary vein isolation procedure.
Time frame: (4-6 hours) Measured during the procedure.
Fluoroscopy Time
A cumulative measurement of flouroscopy time during the pulmonary vein isolation procedure.
Time frame: (4-6 Hours) Measured during the procedure.
complications
Did the patient experience any complication during the actual pulmonary vein isolation procedure or complication during follow-up related to the procedure?
Time frame: 6 months
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