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

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation

In brief

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.

Key facts

Study ID

NCT07621003

Run by

Asklepios proresearch

People needed

264

Starts

2026-07-01

Expected to finish

2031-03-31

Last updated by the study team

2026-06-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Full record on ClinicalTrials.gov

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