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Taking people in GermanyNo phase

Real-World Results of a Balloon-Based Catheter for Treating Atrial Fibrillation

Follows adults with symptomatic atrial fibrillation treated with a new pulsed field ablation catheter.

Plain-language title generated from the registry record
Registry title: REal-world Valued Outcomes of a noveL Balloon-in-basket pUlsed Field ablaTION Catheter for Atrial Fibrillation RegistrY

Key facts

Where
Frankfurt, GermanySee the site

Where in Germany

  • Mvz Ccb Am Agaplesion Markus KrankenhausFrankfurt, GermanyTaking people

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?
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Trial details

Who runs it
Cardioangiologisches Centrum Bethanien
Trial code
NCT07459387
Record updated
9 March 2026
Original description
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.Read full original descriptionShow less

REVOLUTIONARY Registry

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.

Inclusion: 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: 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; Active systemic infection; LA-Diameter > 60mm; 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.

ClinicalTrials.gov NCT07459387