Feasibility Study of the FARAFLEX Mapping and PFA System

Inclusion Criteria:

1. Age ≥ 18 years of age, or older if required by local law

2. Symptomatic, documented, drug-resistant, Persistent AF

3. Willing and capable of providing informed consent

4. Willing and capable of participating in all follow-up assessments and testingassociated with this clinical investigation at an approved clinical investigationalcenter

Exclusion Criteria:

1. Atrial exclusions - Any of the following atrial conditions:

• Left atrial anteroposterior diameter ≥ 5.5 cm, or if LA diameter not available,non indexed volume >100 ml (by MRI, CT or TTE report or physician note)

• Any prior atrial endocardial, epicardial or surgical ablation procedure foratrial arrhythmia other than ablation for right sided SVT

• Current atrial myxoma

• Any PV abnormality, stenosis, or stenting (common and middle PVs areadmissible)

• Current left atrial thrombus

2. Cardiovascular exclusions - Any of the following CV conditions:

• History of sustained ventricular tachycardia or any ventricular fibrillation AFthat is secondary to electrolyte imbalance, thyroid disease, alcohol, or otherreversible / non-cardiac causes

• Current or anticipated pacemaker, implantable cardioverter defibrillator orcardiac resynchronization therapy devices, interatrial baffle, closure device,patch, or patent foramen ovale occluder, LA appendage closure, device orocclusion

• Valvular disease that is symptomatic or is the cause of heart failure.

• Hypertrophic cardiomyopathy

• Any prosthetic heart valve, ring or repair including balloon aorticvalvuloplasty

• Known inability to obtain vascular access or other contraindication to femoralaccess

• Rheumatic heart disease

• Awaiting cardiac transplantation or other cardiac surgery within the next 12months

• Known allergic drug reaction to nitroglycerin1

• Known severe non-revascularizable coronary disease

• Pre-existing right coronary artery stent and left circumflex artery

3. Any of the following conditions at baseline:

• Heart failure associated with NYHA Class IV

• LVEF < 40%

• Uncontrolled hypertension (SBP > 160 mmHg or DBP > 95 mmHg on two (2) BPmeasurements at baseline assessment

• Severe right ventricular dysfunction with documented echocardiography and/orhemodynamic data.

4. Any of the following events within 90 Days of the Consent Date:

• Myocardial infarction (MI), unstable or Prinzmetal angina or coronaryintervention

• Any cardiac surgery

• Heart failure hospitalization

• Pericarditis or symptomatic pericardial effusion

• Gastrointestinal bleeding

• Stroke, TIA, or intracranial bleeding

• Any non-neurologic thromboembolic event

• Carotid stenting or endarterectomy

5. Known coagulopathy disorder (e.g. von Willibrand's disease, hemophilia)

6. Contraindication to, or unwillingness to use, systemic anticoagulation, oracceptable alternatives, pre-, intra- and post-procedure to achieve adequateanticoagulation.

7. Women of childbearing potential who are pregnant, lactating, not using medical birthcontrol or who are planning to become pregnant during the anticipated study period

8. Any of the following health conditions that would prevent participation in thestudy, interfere with assessment or therapy, significantly raise the risk of studyparticipation, or modify outcome data or its interpretation, including but notlimited to:

• Body Mass Index (BMI) > 42.0

• Solid organ or hematologic transplant, or currently being evaluated for atransplant

• Any prior history or current evidence of hemi-diaphragmatic paralysis orparesis

• Severe lung disease, severe pulmonary hypertension, or any lung diseaseinvolving abnormal blood gases or requiring supplemental oxygen

• Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant

• Active malignancy at enrollment (other than squamous cell carcinoma)

• Clinically significant gastrointestinal problems involving the esophagus orstomach including severe or erosive esophagitis, uncontrolled gastric reflux,gastroparesis, esophageal candidiasis or active gastroduodenal ulceration

• Active systemic infection

• Untreated diagnosed obstructive sleep apnea with apnea hypopnea indexclassification of severe (>30 pauses per hour)

• Required use of phosphodiesterase inhibitors within 24 hours of the ablationprocedure

10. Predicted life expectancy less than one (1) year 11. Subjects who are currentlyenrolled in another investigational study or registry that would directly interferewith the current study, except when the subject is participating in a mandatorygovernmental registry, or a purely observational registry with no associatedtreatments; each instance must be brought to the attention of the Sponsor todetermine eligibility 12. Any of the following congenital conditions:

• Congenital heart disease with any clinically significant residual anatomic orconduction abnormality

• History of known congenital methemoglobinemia

• History of known G6PD deficiency