ArcticLine Feasibility Study

This is an interventional device feasibility trial for Atrial Fibrillation Read More

Inclusion Criteria:

• Documentation of symptomatic persistent AF:

  • Defined as having a continuous episode that is sustained beyond 7 days documented via consecutive ECG recordings, or
  • Defined as having a continuous episode that is sustained beyond 7 days documented by an ECG recording and one doctor note indicating the patient had symptoms consistent with AF
• Age 18 through 80 years old
• Failure or intolerance of at least one Class I or III antiarrhythmic drug
• Subject is able and willing to consent to participate in the study and will commit to completion of all follow-up requirements

Exclusion Criteria:

• Longstanding persistent AF, defined as continuous AF greater than 12 month duration
• Left atrial diameter greater than 5.0 cm
• Active systemic infection
• History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure

• Prior left atrial ablation attempt, with exception of:

  • Any pulmonary vein isolation attempt to treat AF, or
  • Successful ablation to treat Wolff-Parkinson White syndrome
• History of left atrial tachycardia
• History of cardiac ablation within 90 days of planned clinical study procedure
• Planned concomitant ventricular ablation
• Cryoglobulinemia

• Structural heart disease of clinical significance including:

  • NYHA Class IV Heart Failure
  • Diagnosed with NYHA Class III Heart Failure for more than six months at time of the study ablation procedure
  • LVEF less than 35%
  • Any cardiac surgery (e.g. CABG) within 3 months of the ablation procedure
  • Any mechanical heart valve, prior aortic or tricuspid valve replacement (e.g. valvotomy, valve replacement), or tricuspid valve repair
  • Severe mitral valve regurgitation or stenosis
  • Significant congenital anomaly or anatomy unable to accommodate device
• Prior surgical maze procedure
• Unstable angina
• Myocardial infarction within 3 months of the ablation procedure
• Presence of primum or secundum atrial septal defect
• Anomalous pulmonary venous return
• Prior surgery for congenital heart disease, including atrial septal defect repair
• Hypertrophic cardiomyopathy with LV septal wall thickness >1.5 cm
• Uncontrolled hyperthyroidism
• Thrombocytosis, thrombocytopenia (including history of heparin-induced thrombocytopenia)
• Severe comorbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate
• History of blood clotting or bleeding abnormalities
• Contraindication to all anticoagulation (e.g. novel oral anticoagulants, heparin or warfarin)
• Pregnant, nursing or planning to become pregnant during study duration
• Enrollment in another clinical trial without prior approval from Medtronic
• Presence or use of left atrial appendage closure device
• Presence of or planned implantation of a pacemaker, implantable cardiac defibrillator, implantable loop recorder or cardiac resynchronization device with permanent lead placement
• Pre-existing hemidiaphragmatic paralysis
• Life expectancy less than one year
• Known drug or alcohol dependency
• Existing pulmonary vein stent(s)