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PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study

RecruitingNAAges 18 Years - anyAllAsklepios proresearch
NCT07621003 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * Persistent AF \>3 years or longstanding persistent AF * Previous AF-Ablation * Ongoing continuous AAD therapy with Amiodarone at baseline * History of failed continuous AAD therapy with \> 1 agent. Exceptions are Beta blocker, Verapamil or "pill in the pocket"-therapy * Left Atrial Volume Index (LAVI) \> 50mL/m2 * Severe mitral regurgitation * Contraindications to anticoagulation 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)
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What it tests

  • Ablation of atrial fibrillation (AF)
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Where

10 sites
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

…and 2 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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