The Evaluation of User Experience With FARAVIEW™ Technology of the OPAL HDx™ Mapping System When Used With the FARAWAVE NAV™ ULTRA Pulsed Field Ablation Catheter in the Treatment of Atrial Fibrillation

Prior treatment

• Any of the following atrial conditions:
  • Left atrial anteroposterior diameter ≥ 6.5 cm, or if LA diameter not available, non-indexed volume > 250 mL
  • Any prior atrial surgery
  • Current atrial myxoma
  • Current Left Atrial Thrombus
  • Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible)

Other illness

• Any of the following cardiovascular conditions:
  • History of sustained ventricular tachycardia (VT) or any ventricular fibrillation (VF)
  • Atrial fibrillation that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible/non-cardiac causes
  • Current or anticipated pacemaker, implantable cardioverter-defibrillator or cardiac resynchronization therapy devices. Interatrial baffle, patent foramen ovale, or atrial septal defect closure device or patch. Any Left Atrial Appendage (LAA) Closure or Occlusion Device.
  • Presence of any of the following: Any cardiac valve prosthesis, ring, repair or clip, Mitral valve stenosis: moderate or greater, Aortic stenosis: moderate or greater, Severe mitral regurgitation, Severe tricuspid regurgitation
  • Hypertrophic Cardiomyopathy
  • Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
  • Awaiting cardiac transplantation or other planned cardiac surgery within the next 12 months
• Any of the following congenital conditions: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
• Any of the following events within 90 days of the Consent Date:
  • Myocardial infarction (MI), unstable angina or coronary intervention
  • Pericarditis or symptomatic pericardial effusion
  • Gastrointestinal bleeding
  • Any Cardiac Surgery
  • Stroke, TIA, or intracranial bleeding
  • Any active non-neurologic thrombus and/or thromboembolic event
  • Carotid stenting or endarterectomy
  • Uncontrolled diabetes mellitus or a recorded HgbA1c > 8.0%

Lab values

• Any of the following conditions at Baseline:
  • Heart failure associated with NYHA Class III and IV
  • Most recent documented LVEF < 40% within the previous 12 months
  • Body Mass Index (BMI) > 45.0 kg/m2
  • Known coagulopathy or bleeding disorder
  • Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation
  • Women who are confirmed to be pregnant or lactating at the time of the ablation procedure
  • Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen
  • Active malignancy (other than non-melanoma skin cancers)
  • Clinically significant gastrointestinal problems involving the esophagus or stomach including severe or erosive esophagitis, uncontrolled gastric reflux, gastroparesis, esophageal candidiasis or active gastroduodenal ulceration
  • Known active systemic infection
  • Predicted life expectancy of less than one (1) year per investigator medical judgement
  • Subjects who are currently enrolled in another investigational study or registry that would directly interfere with the current study, except when the subject is participating in a mandatory governmental registry, or a purely observational registry with no associated treatments; each instance must be brought to the attention of the Sponsor to determine eligibility
• Any of the following conditions in the Medical History
  • Solid organ or hematologic transplant, or currently being evaluated for a transplant
  • Any prior history or current evidence of hemidiaphragmatic paralysis or paresis
  • Any documented history of Prinzmetal Angina or severe non-revascularizable coronary disease
  • Renal insufficiency if an estimated glomerular filtration rate (eGFR) is < 30 mL / min / 1.73 m2, or with any history of renal dialysis or renal transplant
  • Known allergic drug reaction to nitroglycerin (excluding hypotension)
  • Any other general health conditions that, in the investigator's medical opinion, 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

• At least 18 years old, or older if required by law.
• Subjects meeting criteria for Paroxysmal Atrial Fibrillation or Persistent Atrial Fibrillation per the IFU.
• Subjects must be either de novo subjects: left atrial catheter ablation procedure performed for the treatment of atrial fibrillation.
  • OR redo subjects: i. A single prior catheter ablation procedure for the treatment of atrial fibrillation is permitted.
  • The prior ablation procedure must have been limited to documented Pulmonary Vein Isolation (PVI) and/or documented Posterior Wall Isolation (PWI) only iii. Right atrial-only procedures for CTI-dependent flutter do not count as prior atrial fibrillation ablation procedures.
• Willing and capable of providing informed consent
• Willing and capable of participating in all follow up assessments and testing associated with this clinical investigation at an approved clinical investigational center