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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAsklepios proresearch

About this trial

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 criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Ablation of atrial fibrillation (AF)

Treatment groups

264 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

Asklepios proresearch

Lead sponsor

Atrial Fibrillation Network

Collaborator

Abbott

Collaborator