IMPULSE is a prospective, single-arm, multi-center, safety and feasibility study evaluating the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.) for the treatment of paroxysmal atrial fibrillation.
Patients undergoing catheter ablation for paroxysmal atrial fibrillation will be screened for enrollment per protocol inclusion and exclusion criteria. Enrolled patients will then undergo ablation using the IOWA Approach Endocardial Ablation System (FARAPULSE, Inc.). 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 PEF catheter ablation procedure.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Endocardial ablation using the IOWA Approach Endocardial Ablation System
Nemocnice Na Homolce
Prague, Czechia
CHU Bordeaux
Pessac, France
The Primary Safety Endpoint for This Study is the Incidence of Early-onset (Within 7 Days of the PEF Ablation Procedure) Primary Adverse Events (AEs).
The primary safety endpoint for this study is the incidence of early-onset (within 7 days of the PEF ablation procedure) primary adverse events (AEs). * Death * Myocardial infarction (MI) * Pulmonary vein (PV) stenosis† * Diaphragmatic paralysis * Atrio-esophageal fistula† * Transient Ischemic Attack (TIA) * Stroke/Cerebrovascular accident (CVA) Thromboembolism * Pericarditis requiring intervention (major) * Cardiac Tamponade/Perforation * Pneumothorax * Vascular Access Complications * Pulmonary edema * Hospitalization (initial and prolonged)\* * Heart block * Excludes hospitalization (initial \& prolonged) solely due to arrhythmia (AF/Atrial Flutter/Atrial Tachycardia) recurrence or due to non-urgent cardioversion (pharmacological or electrical). * Pulmonary vein (PV) stenosis or atrio-esophageal fistula that occurs greater than one week (7 days) post-procedure shall be deemed a Primary AE.
Time frame: 7 days
Feasibility: Number of Patients With Pulmonary Vein Isolation
Percentage of subjects achieving pulmonary vein isolation using the IOWA Approach Endocardial Ablation System.
Time frame: 1 Day (Acute)
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