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NCT07459387Recruiting

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

REVOLUTIONARY Registry

Source: ClinicalTrials.gov · Last updated 9 Mar 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
1000 (estimated)
First submitted
29 Jan 2026
Start date
7 Oct 2025
Primary completion date
7 Oct 2027
Lead sponsor
Cardioangiologisches Centrum Bethanien
NCT number
NCT07459387

What you commit to

  • Study type: Interventional
  • Planned participants: 1000
  • From 7 Oct 2025 to the primary completion date, 7 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Severe mitral stenosis or regurgitation, prior mitral valve reconstruction or replacement

Other illness

  • 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

Other

  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Mvz Ccb Am Agaplesion Markus Krankenhaus
Coordinator of this site? Confirm its status
FrankfurtGermanyRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.