Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System

Prior treatment

• Cardiovascular exclusions - Any of the following CV conditions:
  • History of sustained ventricular tachycardia or any ventricular fibrillation
  • AF that is secondary to electrolyte imbalance, thyroid disease, alcohol, or other reversible / non-cardiac causes
  • Current or anticipated implantable cardioverter defibrillator, cardiac resynchronization therapy devices, or implantable loop recorders, other than LUX-Dx. Patients with a pacemaker are permitted; however, pacemaker-dependent patients are excluded.
  • Prior interatrial baffle, atrial septal patch, atrial septal defect closure device, patent foramen ovale occluder Left atrial appendage closure devices are excluded, with the exception of WATCHMAN. WATCHMAN is excluded if implanted within 90 days of enrollment
  • Presence of any of the following:
  • Any prosthetic heart valve, ring or repair
  • Moderate to severe mitral valve stenosis
  • More than moderate mitral regurgitation (\>3+)
  • Moderate to severe aortic stenosis
  • Hypertrophic cardiomyopathy
  • Any IVC filter, known inability to obtain vascular access or other contraindication to femoral access
  • Awaiting cardiac transplantation or other cardiac surgery within the next 12 months
  • Severe right ventricular dysfunction with documented echocardiography and/or hemodynamic data.

Other illness

• 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 (physician note or imaging) b. Current atrial myxoma c. Any PV abnormality, stenosis, or stenting (common and middle PVs are admissible) d. Current left atrial thrombus
• Any of the following events within 90 Days of the Consent Date:
  • Coronary disease: Myocardial infarction (MI), unstable or Prinzmetal angina or coronary intervention within 90 days of consent or any documented history of severe non-revascularize coronary disease
  • Cardiac surgery: Any cardiac surgery
  • Heart failure hospitalization: Heart failure hospitalization
  • Pericardium: Pericarditis or symptomatic pericardial effusion
  • GI bleeding: Gastrointestinal bleeding
  • Neurovascular event: Stroke, TIA, or intracranial bleeding
  • Thromboembolism: Any active non-neurologic thrombus and/or thromboembolic event
  • Carotid intervention: Carotid stenting or endarterectomy
  • Diabetes: Uncontrolled diabetes mellitus or a recorded HgbA1c \> 8.0%
• Any of the following congenital conditions:
  • Congenital heart disease: Congenital heart disease with any clinically significant residual anatomic or conduction abnormality
  • Methemoglobinemia: History of known congenital methemoglobinemia
  • G6PD deficiency: History of known G6PD deficiency

Lab values

• Any of the following conditions at baseline:
  • Heart failure associated with NYHA Class III or IV
  • Documented LVEF \< 40% as documented within the previous 12 months
  • Uncontrolled hypertension (SBP \> 160 mmHg or DBP \> 95 mmHg on two (2) BP measurements at baseline assessment not attributable to white coat syndrome per Investigator opinion
  • Body Mass Index (BMI) \>45.0
  • CHA2DS2-VASc score ≥5
• Any of the following conditions:
  • Transplantation: Solid organ or hematologic transplant, or currently being evaluated for a transplant
  • Diaphragmatic abnormality: Any prior history or current evidence of hemi-diaphragmatic paralysis or paresis.
  • Pulmonary: Severe lung disease, severe pulmonary hypertension, or any lung disease involving abnormal blood gases or requiring supplemental oxygen d. Renal: 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 e. Malignancy: Active malignancy (other than squamous cell carcinoma) f. Gastrointestinal: 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. Infections: Active systemic infection h. Required use of phosphodiesterase inhibitors within 24 hours of the ablation procedure i. Nitroglycerin intolerance: Known allergic drug reaction to nitroglycerin (excluding hypotension) j. Hematologic condition: Known coagulopathy or bleeding disorder (e.g. von Willebrand disease, hemophilia) k. Contraindication to anticoagulation: Contraindication to, or unwillingness to use, systemic anticoagulation, or acceptable alternatives, pre-, intra- and post-procedure to achieve adequate anticoagulation.
  • Pregnancy: 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 m. General health conditions: 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.
  • LUX-Dx ICM intolerance: Unwillingness to receive, or unable to tolerate, a subcutaneous, chronically inserted LUX-Dx ICM device o. Participation in another trial: 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.
  • Life expectancy: Predicted life expectancy less than one (1) year

• ≥ 18 years of age, or older if required by local law
• Single previous endocardial AF ablation procedure for PAF or PersAF that minimally included pulmonary vein isolation
• Documented (physician's note) diagnosis of PersAF either prior to the subject's Index Procedure OR development of PersAF after the Index Procedure.
• Documented evidence of symptomatic AF recurrence at least 60 days after the subject's Index Procedure, captured by any regulatory cleared rhythm monitoring device.
  • OR
• If diagnosed with PersAF prior to the Index Procedure, documented recurrence of symptomatic AF or atypical AFL at least 60 days after the Index Procedure, captured by any regulatory cleared rhythm monitoring device.
• 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