STOP Persistent AF

To demonstrate safety and effectiveness of the Arctic Front Advance™ and Freezor MAX® Cardiac CryoAblation Catheters for the treatment of drug refractory recurrent symptomatic persistent atrial fibrillation.

Heart & Vascular, Heart & Vascular - Electrophysiology
Darryl S. Wells, MD

Inclusion Criteria:

  • Documentation of symptomatic persistent AF: Defined as having a continuous episode lasting longer than 7 days but less than 6 months documented by consecutive ECG recordings
  • Failure or intolerance of at least one Class I or III antiarrhythmic drug
  • Age 18 (or older if required by local law) to 80

Exclusion Criteria:

  • Left atrial diameter > 5.0 cm (anteroposterior)
  • Prior left atrial ablation or surgical procedure (including left atrial appendage closures)
  • Presence or likely implant of a permanent pacemaker, biventricular pacemaker, loop recorder, or any type of implantable cardiac defibrillator (with or without biventricular pacing function) within 12 months
  • Body mass index (BMI) >40
  • Presence of any pulmonary vein stents
  • Presence of any pre-existing pulmonary vein stenosis
  • Pre-existing hemidiaphragmatic paralysis
  • Presence of any cardiac valve prosthesis
  • Moderate or severe mitral valve regurgitation or stenosis
  • Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3 month interval preceding the consent date
  • Unstable angina
  • NYHA Class IV congestive heart failure and/or documented left ventricular ejection fraction (LVEF) less than 45% measure by acceptable cardiac testing (e.g. TTE)
  • Primary pulmonary hypertension
  • Rheumatic heart disease
  • Thrombocytosis, thrombocytopenia
  • Any condition contraindicating chronic anticoagulation
  • Active systemic infection
  • Hypertrophic cardiomyopathy
  • Cryoglobulinemia
  • Uncontrolled hyperthyroidism
  • Any cerebral ischemic event (strokes or TIAs) which occurred during the 6 month interval preceding the consent date
  • Any woman known to be pregnant or breastfeeding, or any woman of child bearing potential who is not on a reliable form of birth regulation method or abstinence
  • Life expectancy less than one year
  • Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
  • Known allergies or hypersensitivities to adhesives
  • Known drug or alcohol dependency
  • Unwilling or unable to comply fully with study procedures and follow-up

Elizabeth Vogt, CCRC