Atrial Fibrillation (AF) ablation is typically performed in predefined anatomic regions of the left atrium without attempting to identify patient-specific areas of interest. This procedure is referred to as Pulmonary Vein Isolation (PVI). The hypothesis in this Study is that a tailored ablation strategy targeting areas of spatio-temporal dispersion in combination with PVI is superior to an anatomical ablation strategy targeting PVI alone for the treatment of persistent AF.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
377
Ablation of spatio-temporal dispersion electrograms in combination with pulmonary vein antrum isolation
VX1-based dispersion mapping
Pulmonary vein antrum isolation
Grandview Medical Center
Birmingham, Alabama, United States
Number of Participants Free From Documented AF After One Ablation Procedure
Freedom from documented AF episodes \> 30 seconds, with or without anti-arrhythmic drugs (AADs), 12 months after a single index ablation procedure
Time frame: 12 months
Number of Participants Free From Documented AF/AT After One or Two Ablation Procedures
Freedom from documented AF/AT episodes \> 30 seconds, after one or two procedures, with or without AADs, at 12 months
Time frame: 12 months
Number of Participants Free From Documented AF/AT After One Ablation Procedure
Freedom from documented AF/AT episodes \> 30 seconds, with or without AADs, 12 months after a single ablation procedure
Time frame: 12 months
Number of Participants With Complications (Safety Composite Endpoint)
Complications at 12 months: death, cerebrovascular events, or serious treatment-related adverse event
Time frame: 12 months
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