Pulsed Field Ablation and Pulsed Field CRyoAbLation in PErsistent AtriaL FibrilLation

Korábbi kezelés

• 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 six (6) months prior to procedure
• Myocardial infarction within the previous six (6) months prior to procedure
• Significant congenital anomaly
  • EC 6 BMI > 40
  • EC 7 Any previous history of cryoglobulinemia (for those patients randomized to the PFCA arm)
  • 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 Stroke or TIA within the last year.
  • 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 conditions such as, mental illness, addictive disease, terminal illness with a life expectancy of less than two years, extensive travel away from the research center that may lead to non-compliance with the protocol procedure or follow up

Más betegség

• EC 4 AF 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

Laborértékek

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

Egyéb

• 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 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

• IC 1 Male or female between the ages of 18 - 80 years
• IC 2 Currently scheduled for an ablation of symptomatic persistent (> 7 days) atrial fibrillation within the past year documented by ECG or Continuous Holter monitoring
• IC 3 Refractory to at least one class I or III AAD. (Refractory defined as not effective or not tolerated)
• IC 4 Willingness, ability, and commitment to participate in baseline and follow-up evaluations for the full length of the study
• IC 5 Willingness and ability to give an informed consent