ZERO-AFClinical Evaluation of the Blazer Open-Irrigated Ablation Catheter for the Treatment of Paroxysmal Atrial Fibrillation

Fecha de inicio: 1 de octubre de 2012

Inclusion Criteria: History of recurrent symptomatic PAF with ≥2 episodes reported within the 365 days prior to enrollment o PAF is AF episodes that last ≥30 seconds in duration and terminate within 7 days. At least 1 episode of PAF documented by Holter monitor, rhythm strip, trans-telephonic monitor (TTM), or 12-lead ECG in the 365 days prior to enrollment Refractory to at least one Beta Blocker, Calcium Channel Blocker, Class I OR Class III anti-arrhythmic drug (AAD) Age 18 or above, or of legal age to give informed consent specific to state and national law Competent and willing to provide written informed consent to participate in the study and agree to comply with follow-up visits and evaluation Exclusion Criteria: Have any of the following heart conditions within 90 days prior to enrollment: New York Heart Association (NYHA) Class III or IV Left ventricular ejection fraction (LVEF) <35% Left atrial (LA) diameter >5.5 cm Unstable angina or ongoing myocardial ischemia Transmural myocardial infarction (MI) Congenital structural heart disease that increases the risk of ablation or precludes catheter placement Undergone any left atrial catheter or surgical ablation Have had a coronary intervention, cardiac surgery, or other cardiac ablation within 90 days prior to enrollment Had >1 AF episode lasting greater than 7 days, with no episodes having lasted greater than 30 days, within the past year Subjects regularly prescribed amiodarone therapy during the 120 days prior to enrollment Contraindication to anticoagulation therapy Creatinine >2.5mg/dl or creatinine clearance <30mL/min within 90 days (3 months) prior to enrollment Prosthetic mitral or tricuspid heart valves Confirmed cardiac thrombus within 30 days (1 month) prior to enrollment Implanted pacemaker, ICD, or CRT leads within 180 days (6 months) prior to enrollment History of CVA, TIA or PE within 180 days (6 months) prior to enrollment Left atrial appendage closure device Any other significant uncontrolled or unstable medical condition (e.g. sepsis, acute metabolic illness, end stage COPD) Enrolled in any concurrent clinical trial without documented pre-approval from BSC Women who are pregnant or plan to become pregnant within the course of their participation in the investigation Life expectancy ≤ 2 years (730 days) per physician opinion