Overview
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.
Description
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.
Eligibility
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
