First-line cryoablation for early treatment of Persistent Atrial Fibrillation – a randomized study comparing early trigger isolation using the Cryoballoon versus antiarrhythmic medication

Atrial fibrillation (AF) causes poor quality of life, stroke, hospitalizations and death. Antiarrhythmic drugs (AAD) are first-line therapy, albeit only 40% are free from AF after 12 months.

As AF progress to more sustainable forms in 15-35% and retrospective trials show better outcomes with shorter ”diagnosis to AF ablation times”, an early first-line ablation approach may stop remodeling and progression.

First-line cryoablation was superior to AAD for paroxysmal AF in randomized trials but trials on persistent AF are lackingThe aim is to assess if first-line cryoablation is superior to AAD in preventing atrial arrhythmia recurrences in persistent AF patients at 12 months.Design: Prospective, multicenter trial with 4-6 university centers, randomizing 190 treatment naive atients with symptomatic persistent AF to first-line cryoballoon ablation or AAD therapy after subcutaneous injection of an implantable cardiac monitor for recording of atrial tachyarrhythmia recurrences (primary endpoint) at 12 months.

Secondary outcomes are AF progression, AF burden, quality of life, symptoms, cognitive function, complications, safety, healthcare use - costs, biomarkers, and left atrial volume/function by echocardiography at 12, 24, and 36 months.If first-line ablation can stop AF recurrences better than AAD it will have important implications for health care payers and guidelines committees in their recommendations of which first-line therapy should be chosen for the general AF population.