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PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
Sponsor: Asklepios proresearch
Summary
This study is a prospective, multicenter, randomized, open-label, blinded end-point, controlled clinical trial to investigate the impact of first line pulsed field ablation during 12 months follow-up in patients with early-stage paroxysmal or persistent atrial fibrillation (\<3 years) compared to usual care, defined as OMT.
Official title: PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
264
Start Date
2026-08-19
Completion Date
2031-03-31
Last Updated
2026-08-24
Healthy Volunteers
No
Conditions
Interventions
Ablation of atrial fibrillation (AF)
PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
Locations (10)
HZD Bad Oeynhausen
Bad Oeynhausen, Germany
Uniklinik Köln
Cologne, Germany
Uniklinik Düsseldorf
Düsseldorf, Germany
CCB Frankfurt
Frankfurt, Germany
Uniklinik Gießen
Giessen, Germany
Arian Sultan
Hamburg, Germany
Marien Hospital Herne
Herne, Germany
Leipzig Herzzentrum HZL
Leipzig, Germany
Lukas Krankenhaus Neuss
Neuss, Germany
Klinikum Nürnberg
Nuremberg, Germany