Table 2.

Exclusion criteria

Exclusion criteria
1. AF that is any of the following: a. Persistent (both early and long-standing) by diagnosis or continuous duration >7 d b. Requires 4 or more direct-current cardioversions in the preceding 12 mo c. Secondary to electrolyte imbalance, thyroid disease, alcohol or other reversible/noncardiac causes
2. Any of the following atrial conditions: a. LA anteroposterior diameter ≥5.5 cm (by MRI, CT, or TTE) b. Any prior atrial endocardial or epicardial ablation procedure, other than right-sided cavotricuspid isthmus ablation or for right-sided SVT c. Any prior atrial surgery d. Intra-atrial septal patch or interatrial shunt e. Atrial myxoma f. Current LA thrombus g. LA appendage closure, device, or occlusion, past or anticipated h. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)
3. At any time, 1 or more of the following cardiovascular procedures, implants, or conditions: a. Sustained ventricular tachycardia or any ventricular fibrillation b. Hemodynamically significant valvular disease: i. Valvular disease that is symptomatic ii. Valvular disease causing or exacerbating congestive heart failure iii. Aortic stenosis: if already characterized, valve area <1.5 cm or gradient >20 mm Hg iv. Mitral stenosis: if already characterized, valve area <1.5 cm or gradient >5 mm Hg v. Aortic or mitral regurgitation associated with abnormal LV function or hemodynamic measurements c. Hypertrophic cardiomyopathy d. Any prosthetic heart valve, ring or repair including balloon aortic valvuloplasty e. Pacemaker, implantable cardioverter defibrillator or cardiac resynchronization therapy devices f. Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access g. History of rheumatic fever h. History of congenital heart disease with any residual anatomic or conduction abnormality
4. Any of the following procedures, implants, or conditions: a. At baseline: i. New York Heart Association functional class III or IV ii. LVEF <40% iii. Symptomatic hypotension iv. Uncontrolled hypertension (SBP >160 mm Hg or DBP >95 mm Hg on 2 BP measurements at baseline assessment) v. Symptomatic bradycardia vi. Implantable loop recorder or insertable cardiac monitor b. Within the 3 mo preceding the Consent Date: i. Myocardial infarction ii. Unstable angina iii. Percutaneous coronary intervention iv. Heart failure hospitalization v. Treatment with amiodarone vi. Pericarditis or symptomatic pericardial effusion vii. Gastrointestinal bleeding c. Within the 6 mo preceding the consent date: i. Heart surgery ii. Stroke, TIA, or intracranial bleeding iii. Any thromboembolic event iv. Carotid stenting or endarterectomy
5.Diagnosed disorder of blood clotting or bleeding diathesis
6.Contraindication to, or unwillingness to use, systemic anticoagulation
7.Patient who is not on anticoagulation therapy for at least 3 wk prior to the ablation procedure
8.Contraindication to both CT and MRI
9.Sensitivity to contrast media not controllable by premedication
10.Women of childbearing potential who are pregnant, lactating, not using medical birth control or who are planning to become pregnant during the anticipated study period
11. Medical conditions that would prevent participation in the study, interfere with assessment or therapy, significantly raise the risk of study participation, or modify outcome data or its interpretation, including but not limited to: a. Body mass index >40.0 kg/m2 b. Solid organ or hematologic transplant, or currently being evaluated for an organ transplant c. Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal insufficiency with an estimated glomerular filtration rate <30 mL/min/1.73 m2, or any history of renal dialysis or renal transplant e. Active malignancy or history of treated malignancy within 24 mo of enrollment (other than cutaneous basal cell or squamous cell carcinoma) f. Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis, or active gastroduodenal ulceration g. Active systemic infection h. COVID-19 disease i. Current confirmed, active COVID-19 disease ii. Current positive test for SARS-CoV-2 iii. Confirmed COVID-19 disease not clinically resolved at least 3 mo prior to the consent date i. Other uncontrolled medical conditions that may modify device effect or increase risk, including uncontrolled diabetes mellitus (HgbA1c > 8.0% if test result already obtained) or active alcohol abuse j. Sleep apnea and: i. An AHI ≥15, or ii. An AHI of ≥5 and ≤14 with documented symptoms of excessive daytime sleepiness, impaired cognition, mood disorders or insomnia, or documented hypertension, ischemic heart disease or history of stroke, iii. Unless compliant with CPAP treatment. k. Predicted life expectancy <1 y
12.Clinically significant psychological condition that in the Investigator’s opinion would prohibit the subject’s ability to meet the protocol requirements.
13.Current or anticipated enrollment in any other randomized, interventional, or Food and Drug Administration–regulated clinical study (data collection for registries or retrospective studies is permitted)
14. Employees/family members of: a. FARAPULSE or any of its affiliates or contractors b. The Investigator, sub-Investigators, or their medical office or practice, or healthcare organizations at which study procedures may be performed

AHI = apnea-hypopnea index; BP = blood pressure; CPAP = continuous positive airway pressure; CT = computed tomography; DBP = diastolic blood pressure; HgbA1c = hemoglobin A1c; IVC = inferior vena cava; LA = left atrial; LV = left ventricular; LVEF = left ventricular ejection fraction; MRI = magnetic resonance imaging; PV = pulmonary vein; SARS-CoV-2 = severe acute respiratory syndrome coronavirus 2; SBP = systolic blood pressure; SVT = supraventricular tachycardia; TTE = transthoracic echocardiography; TIA = transient ischemic attack.