The FARAPULSE FARA-Freedom Trial A Prospective Open Label Single Arm Post Market Clinical Follow-Up Trial of the FARAPULSE Pulsed Field Ablation System in Patients With Paroxysmal Atrial Fibrillation (FARA-Freedom)

This is an interventional treatment trial for Paroxysmal Atrial Fibrillation focused on measuring Catheter Ablation, Pulmonary Vein Isolation (PVI), Atrial Fibrillation (AF), Atrial Flutter, Atrial Tachycardia, Pulsed Field Ablation, Cavo-tricuspid isthmus, Anti-arrhythmic drugs, Atrial Fibrillation Drugs, Cardiac Arrhythmias, Cardiac Ablation, Cardiovascular Diseases, Heart Diseases Read More

Inclusion Criteria:

• Diagnosis of paroxysmal atrial fibrillation (PAF), AND
• Two (2) or more episodes of recurrent PAF during the 6 months preceding the consent Date, AND
• At least 1 episode of Atrial Fibrillation (AF) documented with a tracing within 12 months preceding the consent date.
• Age 18 years or older
• Therapeutic Failure for the treatment of Atrial Fibrillation (effectiveness or intolerance) of at least one active AAD for rhythm control.
• Willing and Capable of providing Informed Consent to undergo study procedures AND
• Participate in all examinations and follow-up visits and tests associated with this clinical study

Exclusion Criteria:

• Any previous left atrial (LA) ablation (except permissible retreatment subjects)
• Any previous LA surgery
• Current intracardiac thrombus (can be treated after thrombus is resolved)
• Presence of any pulmonary vein stents
• Presence of any pre-existing pulmonary vein stenosis
• Body Mass Index (BMI) >45.0
• Anteroposterior Left Atrial diameter > 5.5 cm by TTE/ICE
• Presence of any cardiac valve prosthesis
• Clinically significant mitral valve regurgitation or stenosis
• Myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the Consent Date
• Unstable angina
• Any cardiac surgery which occurred during the 3 month interval preceding the Consent Date
• Any significant congenital heart defect corrected or not (including atrial septal defects or pulmonary vein abnormalities but not including minor PFO)
• NYHA class III or IV congestive heart failure
• Left ventricular ejection fraction (LVEF) < 35%
• 2º (Type II) or 3º atrioventricular block
• Presence of a permanent pacemaker, biventricular pacemaker, atrial defibrillator or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
• Hypertrophic cardiomyopathy
• Active Systemic infection
• Uncontrolled hyperthyroidism
• Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the Consent Date.
• Any woman known to be pregnant
• Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
• Severe lung disease, pulmonary hypertension, or any lung disease associated with chronic abnormal blood gases or requiring supplemental oxygen
• Renal insufficiency with an estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant
• Active malignancy, or history of treated malignancy within 24 months of enrollment (other than cutaneous basal cell or squamous cell carcinoma)
• Life expectancy less than one (1) year
• Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study (data collection for registries or retrospective studies is permitted)
• Unwilling or unable to comply fully with study procedures and followup
• Clinically significant psychological condition that in the Investigator's opinion would prohibit the subject's ability to meet the protocol requirements
• Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus, untreated sleep apnea or active alcohol abuse