arcticline feasibility study

Conditions: Atrial Fibrillation; Atrial Flutter

Summary: the purpose of the arcticline feasibility study is to collect preliminary safety and effectiveness data on the arcticline catheter.


Eligibility criteria:
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)