Cryoballoon catheter ablation vs antiarrhythmic drugs as a first-line therapy for patients with paroxysmal atrial fibrillation: Rationale and design of the international Cryo-FIRST study
American Heart Journal Mar 04, 2020
Hermida JS, Chen J, Meyer C, et al. - Via the Cryo-FIRST trial, researchers aim to compare antiarrhythmic drug (AAD) treatment vs cryoballoon pulmonary vein isolation as first-line therapy in treating naïve patients with atrial fibrillation (AF). They will compare efficacy and safety between the two cohorts and amongst subgroups. As per their primary hypothesis, cryoablation is better than AAD therapy. In order to test this hypothesis, the randomization of patients in a 1:1 design will be done. Primary efficacy endpoint failure is defined as (at least) one episode of atrial arrhythmia with a duration > 30 sec (documented by 7-day Holter or 12-lead ECG) using a 90-day blanking period. Further, quality-of-Life, rehospitalization, arrhythmia recurrence rate, healthcare utilization, and left atrial function will be evaluated as secondary endpoints and evaluation of adverse events will be done. Two hundred eighteen patients will be included in up to 16 centers at study enrollment. As per expectation, the results of this work may assist in selecting patients for early AF disease therapy via cryoballoon ablation.
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