Ablation of atrial fibrillation (AF): PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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)
Primary outcome measure(s)
Freedom from any Atrial Tachyarrhythmia — through 9 weeks to 12 months follow-up Arrhythmia-free survival, defined as freedom from atrial fibrillation, atrial flutter, or atrial tachycardia lasting \>30 seconds through 9 weeks to 12 months follow-up on ILR monitoring via blinded core lab or any 12 lead ECG on visits, ECG Holter monitoring, or on symptom driven event monitoring after a 8 week Blanking period (reviewed by a blinded endpoint review committee).
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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