Demonstrate the safety and effectiveness of the Ablacath™ Mapping Catheter and Ablamap® System in patients with all types of atrial fibrillation (AF) including paroxysmal or persistent or long-standing persistent, undergoing and De Novo or Redo procedures. Phenotype patients and demonstrate the prognostication power of Electrographic Flow (EGF®) maps among all subjects using 12-month follow-up outcomes following EGF-guided mapping and ablation.
Subjects with all types of AF who are candidates for catheter ablation of their AF. The study will enroll up to 400 subjects in 25 centers globally.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
In addition to standard touch-up of pulmonary vein isolation, subjects receive targeted source ablation guided by Electrographic Flow™ (EGF) mapping. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are considered significant and targeted with radiofrequency ablation. The procedure concludes when all EGF-identified sources are eliminated, defined as reducing source activity below the threshold.
In addition to standard pulmonary vein isolation (PVI), subjects receive Electrographic Flow™ (EGF) mapping. PVI may be performed using any commercially available platform/catheter. EGF mapping enables the full spatiotemporal reconstruction of organized atrial electrical wavefront propagation to identify active sources or origins of excitation that may trigger atrial fibrillation (AF). EGF-identified sources with activity above the threshold (≥ 25%) are marked as relevant; however, no EGF-guided ablations are performed during this index procedure. If subjects have AF recurrence after the 90-day blanking period, they may undergo a recurrence procedure and EGF-guided ablation.
University of Alabama
Birmingham, Alabama, United States
Grandview Medical Center
Birmingham, Alabama, United States
Banner Health
Phoenix, Arizona, United States
Sutter Health Sequoia Heart and Vascular Institute
Redwood City, California, United States
Pacific Heart Institute
Santa Monica, California, United States
Colorado Heart
Golden, Colorado, United States
Florida Heart Rhythm Specialists
Fort Lauderdale, Florida, United States
Ascension Medical Group
Jacksonville, Florida, United States
Piedmont Health
Athens, Georgia, United States
Beaumont Health
Royal Oak, Michigan, United States
...and 14 more locations
Number of participants with 12-month freedom from AF recurrence (with or without AADs)
This measure represents the number of subjects with freedom from documented episodes of atrial fibrillation (AF) recurrence lasting longer than 30 seconds from the 90-day post-procedure blanking period through 12 months of follow-up (with or without AADs).
Time frame: From 90 days to 12 months after index procedure
Number of participants with freedom from a composite of serious adverse events (SAEs) occurring within 7 days from the index procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Time frame: From index procedure to 7 days after index procedure
Demonstrate the predictive value of electrographic flow (EGF) phenotyping for ablation outcome
Time frame: 12 months
Number of participants with freedom from a composite of SAE occurring within 30 days from post-index ablation procedure
Evaluated by assessing combined rate of SAE composite as adjudicated by a CEC for relatedness to device or procedure
Time frame: From index procedure to 30 days after index procedure
Overall reduction in burden of AF for subset of patients with implantable loop recorder
Evaluation of patient's freedom from AF based on recordings of implantable loop recorders
Time frame: From 90 days to 12 months after index procedure
Overall procedure time, fluoro time, total EGF-guided mapping time, total EGF-guided ablation time
Evaluation of index or recurrence procedure data
Time frame: Index or Repeat Procedure
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