Clinical Trials

Inclusion Criteria:

• Male or female, between the ages of 18 and 80 years.
• 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:
  • Physician’s note indicating continuous AF > 7 days and ≤ 12 months; and
  • One of the following:
  • 24-hour Holter within 180 days of enrollment showing continuous AF; or
  • 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..
• Refractory to at least one class I or III AAD. (Refractory defined as not effective, not tolerated or not desired).
• Willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study.
• Willingness and ability to give an informed consent.

Exclusion Criteria:

• 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.
• Any duration of continuous AF lasting longer than 12-months.
• History of previous left atrial ablation or surgical treatment for AF/AFL/AT.
• Atrial fibrillation secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause.
• Structural heart disease as described below:
  • Left ventricular ejection fraction (LVEF) < 40% based on most recent TTE;
  • Left atrial size > 55 mm (parasternal long axis view) documented within 6-months of screening;
  • NYHA Class III or IV heart failure documented within the previous 12-months;
  • An implanted pacemaker or ICD;
  • Previous cardiac surgery, ventriculotomy, or atriotomy (excluding atriotomy for CABG);
  • Previous cardiac valvular surgical or percutaneous procedure, or prosthetic valve;
  • Interatrial baffle, closure device, patch, or PFO occluder;
  • Presence of a left atrial appendage occlusion device;
  • Presence of any pulmonary vein stenting devices;
  • Coronary artery bypass graft (CABG) or PTCA procedure within 6 months prior to procedure;
  • Unstable angina or ongoing myocardial ischemia;
  • Myocardial infarction within the previous six (6) months prior to procedure;
  • Moderate or severe mitral insufficiency or stenosis based on most recent TTE;
  • Atrial myxoma;
  • Significant congential anomaly.
• BMI > 40.
  • BMI > 35 and no prior sponsor approval into the study.
• Any previous history of cryoglobulinemia.
• History of blood clotting or bleeding disease.
• History of severe COPD requiring steroid use in the previous 12-months.
• History of severe sleep apnea (AHI > 30) not currently treated with a CPAP machine or other mechanical device.
• Any prior history of documented cerebral infarct including recent TIA (within one year) or systemic embolism (excluding a post-operative DVT)
• ANY prior history of documented cerebral infarct or systemic embolism (excluding a post-operative DVT).
• Any prior history or current evidence of hemidiaphragmatic paralysis.
• Pregnant or lactating (current or anticipated during study follow-up).
• 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.
• 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).

Eligibility last updated 10/13/21. Questions regarding updates should be directed to the study team contact.