BaLloon-based PFA Ablation poST Approval Outcomes for PAF and PersAF

Prior treatment

• Contraindication to long term anti-thromboembolic therapy
• Previous left atrial surgical or left atrial catheter ablation procedure (including LAA closure device)
• Previous tricuspid or mitral valve replacement or repair

Other illness

• Arrhythmia due to reversible causes including thyroid disorders, acute alcohol intoxication, electrolyte imbalance, severe untreated sleep apnea, and other major surgical procedures in the preceding 90 days
• Known presence of cardiac thrombus
• New York Heart Association (NYHA) class III or IV heart failure
• Myocardial infarction (MI), acute coronary syndrome, percutaneous coronary intervention (PCI), or valve or coronary bypass grafting surgery within preceding 90 days
• Unstable angina
• Stroke or TIA (transient ischemic attack) within the last 90 days
• Heart disease in which corrective surgery is anticipated within 180 days after procedure
• History of blood clotting or bleeding abnormalities including thrombocytosis, thrombocytopenia, bleeding diathesis, or suspected anti-coagulant state
• Rheumatic heart disease
• Active systemic infection
• Renal failure requiring dialysis
• Severe pulmonary disease (e.g., restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces severe chronic symptoms
• Presence of other medical, anatomic, comorbid, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.

Lab values

• Known Left ventricular ejection fraction \< 35% as assessed with echocardiography within 360 days of index procedure

Other

• Pregnant, nursing, or planning to become pregnant during the clinical investigation follow-up period
• Patients who have had a ventriculotomy or atriotomy within the preceding 30 days of procedure
• Patient unable to receive heparin or an acceptable alternative to achieve adequate anticoagulation
• Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
• Patients with prosthetic valves
• Patients with a myxoma
• Patients with an interatrial baffle or patch as the transseptal puncture could persist and produce an iatrogenic atrial shunt
• Stent, constriction, or stenosis in a pulmonary vein
• Hypertrophic cardiomyopathy
• Diagnosed with amyloidosis or atrial amyloidosis
• Presence of an implanted LAA closure device
• Patient is currently participating in another clinical study that may confound the results of this of this post market evaluation; for example, enrolled in another study with an active treatment arm
• Unlikely to survive the protocol follow up period of 12 months
• Individuals without legal authority
• Individuals unable to read or write

• Documented symptomatic PAF or PersAF. Documentation requirements are as follows:
  • Paroxysmal:
  • Physician's note indicating recurrent self-terminating AF AND
  • One electrocardiographically documented PAF episode within 12 months prior to enrollment.
  • Persistent: Continuous AF sustained beyond 7 days and less than 1 year that is documented by
  • Physician's note, AND either
  • 24-hour Holter within 360 days prior to enrollment, showing continuous AF, OR
  • Two electrocardiograms (from any form of rhythm monitoring) showing continuous AF:
  • That are taken at least 7 days apart but less than 12 months apart
  • If electrograms are more than 12 months apart, there must be one or more Sinus Rhythm recordings in between or within 12 months prior to consent/enrollment
  • The most recent electrocardiogram must be within 180 days of enrollment.
  • NOTE: Documented evidence of the AF episode must either be continuous AF on a 12-lead ECG or include at least 30 seconds of AF from another ECG device.
• Plans to undergo a de novo ablation procedure with the Volt PFA Catheter due to symptomatic PAF or PersAF and is refractory, intolerant, or contraindicated to at least one Class I-IV AAD medication
• At least 18 years of age
• Able and willing to comply with all trial requirements including pre-procedure, post- procedure, and follow-up testing and requirements
• Informed of the nature of the trial, agreed to its provisions, and has provided written informed consent as approved by the Institutional Review Board/Ethics Committee (IRB/EC) of the respective clinical trial site.