REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY

REVOLUTIONARY Registry

describe real-world adaption, work-flow data as well as procedural and follow-up outcomes after balloon-in-basket guided PFA for AF in early European users.

A prospective, multi-center registry, REal-world Valued Outcomes of a noveL balloon-in-basket pUlsed field ablaTION catheter for Atrial fibrillation RegistrY - the REVOLUTIONARY Registry - was designed. All-comer data of patients with symptomatic atrial fibrillation (AF) who underwent catheter ablation using the novel balloon-in-basket PFA catheter will be collected from European high-volume centers who were involved in the early market release of the VOLT (Abbott) technology. Data includes patient demographics, procedural metrics on safety and efficacy as well as follow-up outcome data. Learning curve characteristics and comparison on different workflows will be assessed.

Inclusion Criteria:

All patients who underwent an AF catheter ablation procedure using the novel balloon-in-basket VOLT PFA system will be included into the analysis.

• Age ≥ 18 years
• Subject is able and willing to give informed consent

Exclusion Criteria:

• LA-Diameter > 60mm
• Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement
• Any condition or disease, which is contraindication for AF ablation, up to the assessment of the investigator
• Known intra-cardiac thrombus formation Any contraindication for oral anticoagulation
• Any untreated or uncontrolled hyperthyroidism or other reversible causes for AF like alcoholism
• Pregnant or breastfeeding woman or woman of childbearing potential not on adequate birth control
• Active systemic infection