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

RecruitingNA

Sponsor: Asklepios proresearch

Conditions: Atrial Fibrillation

Interventions: Ablation of atrial fibrillation (AF)

Countries: Germany

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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)

Locations (10)

Bad Oeynhausen, Germany
Cologne, Germany
Düsseldorf, Germany
Frankfurt, Germany
Giessen, Germany
Hamburg, Germany
Herne, Germany
Leipzig, Germany
Neuss, Germany
Nuremberg, Germany