IMPACT is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
Patients with paroxysmal atrial fibrillation scheduled to undergo cardiac surgery will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Cardiac Ablation System (FARAPULSE, Inc.), followed by concomitant cardiac surgery. Subjects will be followed at 7 days, 30 days, 3 months, 6 months and 12 months with a blanking period for recurrent atrial fibrillation or atrial tachycardia of 3 months following the index ablation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
7
Epicardial ablation using the IOWA Approach Cardiac Ablation System
CHU Bordeaux
Pessac, France
Primary Safety: A Composite Safety Endpoint Consisting of the Subjects That Experience One or More Serious Adverse Events (SAEs) Related to the Investigational Procedure and/or Device Within 30 Days of the Ablation Procedure or Hospital Discharge.
A composite safety endpoint consisting of the proportion of subjects that experience one or more of the following serious adverse events (SAEs) related to the investigational procedure and/or device within 30 days of the PEF (pulsed electric field) ablation procedure or hospital discharge, whichever is later, except as noted below: * Cardiac death * Stroke and/or transient ischemic attack (TIA) * Myocardial infarction (MI) * Excessive bleeding * Atrio-esophageal fistula * Persistent post-surgical phrenic nerve paralysis at 12 months * Severe pulmonary vein stenosis (\>70%)
Time frame: 30 Days
Feasbility: Electrical Isolation of Posterior Left Atrium and Pulmonary Veins.
Proportion of subjects that achieve procedural success. Procedural success is defined as the creation of an electrically isolating "box" lesion encompassing the pulmonary veins and posterior left atrium using the study device.
Time frame: 1 Day (Acute)
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