Balloon-based pulsed field ablation as first treatment for early atrial fibrillation
Compares ablation with a balloon to usual medical care in early atrial fibrillation.
Plain-language title generated from the registry record
Registry title: PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study
Key facts
- Where
- Bad Oeynhausen, Cologne, Düsseldorf, Frankfurt, Giessen, Hamburg, Herne, Leipzig, Neuss, and Nuremberg, GermanySee the 10 sites
Where in Germany
- HZD Bad OeynhausenBad Oeynhausen, GermanyNot yet recruiting
- Uniklinik KölnCologne, GermanyNot yet recruiting
- Uniklinik DüsseldorfDüsseldorf, GermanyNot yet recruiting
- CCB FrankfurtFrankfurt, GermanyNot yet recruiting
- Uniklinik GießenGiessen, GermanyNot yet recruiting
- Arian SultanHamburg, GermanyTaking people
- Marien Hospital HerneHerne, GermanyNot yet recruiting
- Leipzig Herzzentrum HZLLeipzig, GermanyNot yet recruiting
- Lukas Krankenhaus NeussNeuss, GermanyTaking people
- Klinikum NürnbergNuremberg, GermanyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Asklepios proresearch
- Trial code
- NCT07621003
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"
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.
Inclusion: Adults (≥18 years) with symptomatic or asymptomatic, paroxysmal or persistent atrial fibrillation; First diagnosis of AF within the last 36 months; At least one documented episode of AF on ECG, Holter monitoring, or eligible Smart Watch Device; No prior catheter ablation for AF.
Exclusion: Previous AF-Ablation; Ongoing continuous AAD therapy with Amiodarone at baseline; Contraindications to anticoagulation therapy; History of failed continuous AAD therapy with > 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy; Severe pulmonary or renal disease; Pregnancy, active cancer disease; Any condition or disease which is contraindication for AF ablation within 21 days or Anti-Arrhythmic Drug (AAD); Persistent AF >3 years or longstanding persistent AF; Left Atrial Volume Index (LAVI) > 50mL/m2; Severe mitral regurgitation.