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RECRUITING
NCT07621003
NA

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

Sponsor: Asklepios proresearch

View on ClinicalTrials.gov

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.

Official title: PULSed Field Ablation for Atrial Fibrillation Using a Balloon for Early Intervention - Study - The "PULSE - Study"

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

264

Start Date

2026-08-19

Completion Date

2031-03-31

Last Updated

2026-08-24

Healthy Volunteers

No

Interventions

PROCEDURE

Ablation of atrial fibrillation (AF)

PFA (Pulse Field Ablation) - Pulmonary vein isolation ablation for atrial fibrillation

Locations (10)

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

Lukas Krankenhaus Neuss

Neuss, Germany

Klinikum Nürnberg

Nuremberg, Germany