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

Recruiting now · Not applicable

Conditions studied: Treatment of Atrial Fibrilation, Symptomatic Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT07459387

Run by

Cardioangiologisches Centrum Bethanien

People needed

1000

Starts

2025-10-07

Expected to finish

2027-10-07

Last updated by the study team

2026-03-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Mvz Ccb Am Agaplesion Markus Krankenhaus — Frankfurt, Germany (enrolling)

Full record on ClinicalTrials.gov

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