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

NCT07621003 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 264

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

Interventions

PROCEDURE

Ablation of atrial fibrillation (AF)

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

Sponsors & Collaborators

  • Atrial Fibrillation Network

    collaborator OTHER

  • Abbott

    collaborator INDUSTRY

  • Asklepios proresearch

    lead INDUSTRY

Principal Investigators

  • Arian Sultan, MD, PhD · Asklepios Klinik St. Georg

  • Stephan Willems, MD, PhD · Asklepios Klinik St. Georg

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-17
Primary Completion
2030-03-31
Completion
2031-03-31

Countries

  • Germany

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07621003 on ClinicalTrials.gov