tailored treatment of permanent atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this trial is to evaluate the safety and efficacy of the medtronic cardiac ablation system compared to medical therapy in the persistent and long-standing persistent atrial fibrillation population.


Eligibility criteria:
inclusion criteria: * history of symptomatic, continuous atrial fibrillation defined as: continuous atrial fibrillation lasting greater than 1 year but less than 4 years or nonself-terminating atrial fibrillation, lasting greater than 7 days but no more than 1 year, with at least one failed direct current cardioversion. a failed cardioversion was defined as an unsuccessful cardioversion or one in which normal sinus rhythm was established but not maintained beyond 7 days. * atrial fibrillation symptoms included the following: palpitations, fatigue,exertional dyspnea, exercise intolerance * age between 18 and 70 years * failure of at least one class i or iii rhythm control drug * willingness, ability and commitment to participate in baseline and follow-up evaluations for the full length of the study. exclusion criteria: * structural heart disease of clinical significance including: * previous cardiac surgery (excluding coronary artery bypass graft and mitral valve repair) * symptoms of congestive heart failure including, but not limited to, new york heart association (nyha) class iii or iv congestive heart failure and/or documented ejection fraction \<40% measured by acceptable cardiac testing * left atrial diameter \>55 mm * moderate to severe mitral or aortic valvular heart disease * stable/unstable angina or ongoing myocardial ischemia * myocardial infarction (mi) within 3 months of enrollment * congenital heart disease (not including atrial septal defect or patent foramen ovale without a right to left shunt) where the underlying abnormality increases the risk of an ablative procedure * prior atrial septal defect of patent foramen ovale closure with a device using a percutaneous approach * hypertrophic cardiomyopathy (left ventricular septal wall thickness \>1.5 cm) * pulmonary hypertension (mean or systolic pulmonary artery pressure \>50 mm hg on doppler echo) * any prior ablation for atrial fibrillation * enrollment in any other ongoing arrhythmia study * any ventricular tachyarrhythmia currently being treated where the arrhythmia or the management may interfere with this study * active infection or sepsis * any history of cerebral vascular disease including stroke or transient ischemic attacks * pregnancy or lactation * left atrial thrombus at the time of ablation * untreatable allergy to contrast media * any diagnosis of atrial fibrillation secondary to electrolyte imbalance, thyroid disease, or any other reversible or non-cardiovascular causes * history of blood clotting (bleeding or thrombotic) abnormalities * known sensitivities to heparin or warfarin * severe chronic obstructive pulmonary disease (defined as forced expiratory volume 1 (fev1) \<1) * severe co-morbidity or poor general physical/mental health that, in the opinion of the investigator, will not allow the subject to be a good study candidate

Keywords: atrial fibrillation