cryoballoon ablation for early persistent atrial fibrillation (cryo4 persistent af)

Conditions: Atrial Fibrillation

Summary: the purpose of this clinical study is to assess the single procedure outcomes of using cryoballoon ablation without additional empirical lesions and/or complex fractionated electrogram (cfe) ablations for patients with early persistent atrial fibrillation (\<1 year from first diagnosis of persistent af).


Eligibility criteria:
inclusion criteria: * patients with documented symptomatic persistent af refractory or intolerant to at least 1 class i or iii antiarrhythmic medication. persistent af defined as: * episode lasting longer than 7 days, but less than 1 year documented by consecutive ecg recordings of 100% af greater than 7 days apart or * episode requiring electrical or pharmacological cardioversion after 48 hours of af documented by continuous recording * date of first diagnosis of persistent af within the last 12 months preceding the consent date * age between 18 and 75 years * willing to comply with study requirements and give informed consent (defined as legally effective, documented confirmation of a subject's (or their legally authorized representative or guardian) voluntary agreement to participate in a particular clinical study) to participate in this clinical study exclusion criteria: * long-standing persistent af (has lasted for ≥1 year) * current diagnosis of paroxysmal af * anteroposterior la diameter \> 5.0 cm by tte * current intracardiac thrombus * presence of one or more pulmonary vein stents * presence of any pre-existing pulmonary vein stenosis * primary pulmonary hypertension * nyha class iv congestive heart failure and/or documented left ventricular ejection fraction (lvef) \< 40% measure by acceptable cardiac testing (e.g. tte) * hypertrophic cardiomyopathy * previous la ablation or surgery * unstable angina * presence of any cardiac valve prosthesis * thrombocytosis, thrombocytopenia * any condition contraindicating chronic anticoagulation * any cardiac surgery, myocardial infarction, pci / ptca or coronary artery stenting which occurred during the 3 month interval preceding the consent date * any cerebral ischemic event (strokes or tias) which occurred during the 6 month interval preceding the consent date * cryoglobulinemia * 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 * uncontrolled hyperthyroidism * any woman known to be pregnant or breastfeeding * active systemic infection * subject is employed by medtronic or by the department of any of the investigators or is a close relative of any of the investigators * life expectancy ≤ 1 year * currently enrolled or plans to participate in a potentially confounding drug or device trial during the course of this study. co-enrollment in concurrent studies is allowed when documented pre-approval is obtained from the medtronic study manager * exclusion criteria as per local laws (for france, this includes, but is not limited to: incompetent adults or patients that are not affiliated to the french social security system)

Keywords: atrial fibrillation persistent atrial fibrillation cryoablation cryoballoon pulmonary vein isolation