high radiofrequency power for faster and safer pulmonary vein ablation trial (power fast iii)

Conditions: Atrial Fibrillation; Catheter Ablation

Summary: multicenter 1:1 randomized study. two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 w guided by lsi \> 6 or ai \> 500 on the anterior aspect of pulmonary veins and power 25 w guided by lsi \>5 or ai \>350 on the posterior wall near the esophagus; 2) point-by-point rf applications with power set at 70 w and duration 9-10 s. the main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ecg transtelephonic transmissions during 1-year follow-up. secondary objectives include total rf time and parameters of acute pv isolation efficacy (first-pass isolation, acute reconnections and dormant conduction).

multicenter 1:1 randomized study: hospital universitario la paz, madrid; hospital clínico universitario san carlos, madrid; hospital clínico y provincial de barcelona, barcelona; complejo hospitalario de navarra, pamplona; hospital clínico universitario de valladolid; hospital clínico universitario de albacete; hospital clínico universitario de alicante; hospital universitario virgen de las nieves, granada; hospital la fe, valencia; hospital clínico de valencia; hospital universitario juan ramón jiménez, huelva; hospital de la ribera, alzira, valencia. españa. spain. two atrial fibrillation ablation strategies are compared: 1) conventional ablation using point-by-point radiofrequency applications with power 40 w guided by lsi \> 6 or ai \> 500 on the anterior aspect of pulmonary veins and power 25-40 w guided by lsi \>5 or ai \>350 on the posterior wall near the esophagus; 2) point-by-point rf applications with power set at 70 w and duration 9-10 s. the main objective of the trial is the incidence of esophageal lesions evaluated with systematic endoscopy and clinical efficacy evaluated with daily ecg transtelephonic transmissions during 1-year follow-up. secondary objectives include total rf time and parameters of acute pv isolation efficacy (first-pass isolation, acute reconnections and dormant conduction). subestudy: asymptomatic cerebral lesions detected by 1,5 t mri \<72 h after ablation. not all centers participate in the subestydy. however, if the center participates, all patients in both ablation groups will be included in the subestudy.

Eligibility criteria:
inclusion criteria: * paroxysmal or persistent atrial fibrillation. * currently accepted class i or ii indication for ablation according to practice guidelines: symptomatic arrhythmia, failure of at least 1 antiarrhythmic drug or patient's manifest preference of ablation instead of drugs. * age \> 18 years. * acceptance of informed consent. exclusion criteria: * previous pulmonary veins ablation of any type. * permanent atrial fibrillation or long-standing persistent af (\>1 year). * heart surgery \<3 months before ablation. * coronary revascularization of any type \<3 months before ablation. * myocardial infarction or acute coronary syndrome \< 3 months before ablation. * stroke or transient cerebral ischaemic attack \< 3 months before ablation. * persistent left atrial thrombus. * contraindication for anticoagulation. * absolute indication of double antiplatelet drugs. * complex congenital heart disease, corrected or not. * any clinical situation absolutely precluding an interventional procedure.