iCLAS™ for Persistent Atrial Fibrillation

Prior treatment

• EC 3 History of previous left atrial ablation or surgical treatment for AF/AFL/AT
• NYHA Class III or IV heart failure documented within the previous 12-months
• Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG),
• Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve
• Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure
• Myocardial infarction within the previous six (6) months prior to procedure
• BMI \>35 and no prior sponsor approval into the study
  • EC 7 Any previous history of cryoglobulinemia
  • EC 8 History of blood clotting or bleeding disease
  • EC 9 History of severe COPD requiring steroid use in the previous 12-months
  • EC 10 History of severe sleep apnea (AHI \> 30) not currently treated with a CPAP machine or other mechanical device
  • EC 11 Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
  • EC 12 Any prior history or current evidence of hemidiaphragmatic paralysis
  • EC 13 Pregnant or lactating (current or anticipated during study follow-up)
  • EC 14 Current enrollment in any other study protocol where testing or results from that study may interfere with the procedure or outcome measurements for this study
  • EC 15 Any other condition that, in the judgment of the investigator, makes the patient a poor candidate for this procedure, the study or compliance with the protocol (includes vulnerable patient population, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center, COVID-19 related concerns)

Other illness

• EC 4 Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause
• EC 5 Structural heart disease as described below:
• Unstable angina or ongoing myocardial ischemia
• Moderate or severe mitral insufficiency or stenosis based on most recent TTE

Lab values

• Left ventricular ejection fraction (LVEF) \< 40% based on most recent TTE

Other

• EC 1 In the opinion of the Investigator, any known contraindication to an atrial ablation, TEE, or anticoagulation. Including, but not limited to, the identification of any atrial thrombus or evidence of sepsis
• EC 2 Any duration of continuous AF lasting longer than 12-months
• Left atrial size \> 55 mm (parasternal long axis view) documented within 6-months of screening
• An implanted pacemaker or ICD
• Interatrial baffle, closure device, patch, or PFO occluder
• Presence of a left atrial appendage occlusion device
• Presence of any pulmonary vein stenting devices
• Atrial myxoma
• Significant congential anomaly
  • EC 6 BMI \> 40

• IC1 Male or female between the ages of 18 and 80 years
• IC2 Currently scheduled for an ablation of symptomatic, PsAF defined as continuous AF that is sustained \> 7-days and ≤ 12 months and documented by the following: a. Physician's note indicating continuous AF \> 7 days and ≤ 12 months, AND b. One of the following: i. 24-hour Holter within 180 days of enrollment showing continuous AF, OR ii. Two electrocardiograms from any forms of rhythm monitoring (e.g., 12-lead ECGs or single lead ECGs) completed ≥ 7 days apart within 180 days of enrollment.
• IC3 Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired)
• IC4 Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study
• IC5 Willingness and ability to give an informed consent