REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial… (NCT07459387) | Clinical Trial Compass
RecruitingNot Applicable
REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY
Germany1,000 participantsStarted 2025-10-07
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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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