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

RECRUITINGN/ASponsored by Cardioangiologisches Centrum Bethanien
Actively Recruiting
PhaseN/A
SponsorCardioangiologisches Centrum Bethanien
Started2025-10-07
Est. completion2027-10-07
Eligibility
Age18 Years+
Healthy vol.Accepted

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.

Eligibility

Age: 18 Years+Healthy volunteers accepted
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

Conditions3

Heart DiseaseSymptomatic Atrial FibrillationTreatment of Atrial Fibrilation

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