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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
View on ClinicalTrials.gov →
NCT07459387
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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Actively Recruiting
PhaseN/A
SponsorCardioangiologisches Centrum Bethanien
Started2025-10-07
Est. completion2027-10-07
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT07459387