Early Atrial Fibrillation Ablation for Stroke Prevention in Patients With High Comorbidity Burden (EASThigh-AFNET 11)

Summary

EASThigh-AFNET 11 is an international, prospective, randomized, open, blinded endpoint assessment, multicenter trial (Treatment Strategy trial).

The objective of EASThigh-AFNET 11 is to investigate whether early atrial fibrillation ablation in patients with atrial fibrillation (AF) and a high comorbidity burden (CHA2DS2-VASc ≥4) reduces cardiovascular events (stroke, cardiovascular death, or heart failure events) compared to usual care.

Conditions

• Atrial Fibrillation

Interventions

OTHER

Early atrial fibrillation ablation

Patients randomised to early atrial fibrillation ablation will undergo pulmonary vein isolation within 2 months after randomisation.

OTHER

Usual Care

Usual care will consist of optimal AF therapy based on guideline recommendations and local protocols and usage.The choice of therapies and medications follows routine care in line with medical guidelines and local policies at the discretion of the treating physician and should be based on the individual medical status of each study patient.

Sponsors & Collaborators

• Atrial Fibrillation Network

  lead OTHER

Principal Investigators

• Paulus Kirchhof, Prof. Dr. · University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

• Andreas Rillig, PD Dr. · University Heart and Vascular Center Hamburg, University Hospital Hamburg Eppendorf

• Jason Andrade, Prof. Dr. · University of British Columbia, Vancouver General Hospital, Department of Electrophysiology

• André Ng, Prof. Dr. · Department of Cardiovascular Sciences, University of Leicester

• Prash Sanders, Prof. Dr. · Centre for Heart Rhythm Disorders, University of Adelaide, Royal Adelaide Hospital

• Volker Straub · Patient representative

• Kevin Vernooy, Prof. Dr. · Department of Cardiology, Cardiovascular Research Institute Maastricht (CARIM), Maastricht University Medical Center (MUMC)

• Antonia Zapf, Prof. Dr. · Institute of Medical Biometry and Epidemiology, University Medical Center Hamburg-Eppendorf

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-10-14

Primary Completion

2030-02-28

Completion

2030-05-31

Countries

• Australia
• Canada
• Germany
• Netherlands
• Poland
• Spain
• United Kingdom