Early Treatment of Atrial Fibrillation for Stroke Prevention Trial

NCT01288352 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2789

Last updated 2020-07-23

No results posted yet for this study

Summary

EAST prospectively tests the hypothesis that an early, structured rhythm control therapy based on antiarrhythmic drugs and catheter ablation can prevent atrial fibrillation (AF) related complications in patients with AF when compared to usual care.

Patients will be randomized to early therapy or usual care. In the early therapy group, patients will receive either catheter ablation (usually by pulmonary vein isolation), or adequate antiarrhythmic drug therapy at an early time point. The initial therapy will be selected by the local investigator. Upon AF recurrence, both modalities will be combined.

Usual care will be conducted following the 2010European Society of Cardiology ( ESC )guidelines for AF treatment. Early rhythm control therapy will be guided by Electrocardiogram (ECG) monitoring.

Conditions

Interventions

OTHER

early standardised rhythm control

Patients in the early therapy group will be treated following the same therapeutic recommendations of the ESC guidelines as the usual care group. In addition, rhythm control therapy will be initiated early with the aim of preventing recurrence and delaying or preventing progression of AF. Early-onset rhythm control therapy can consist of: 1. Optimal antiarrhythmic drug therapy 2. Catheter ablation with the aim of pulmonary vein isolation (PVI), 3. Antiarrhythmic drug therapy and catheter ablation may be combined and supplemented by early cardioversion in patients with persistent AF. All individual treatment decisions will be taken by the treating study physician considering the labelling of the procedures and drugs and patient preferences.

Sponsors & Collaborators

  • Sanofi

    collaborator INDUSTRY
  • Abbott

    collaborator INDUSTRY
  • The German Heart Foundation

    collaborator OTHER
  • European Heart Rhythm Association (EHRA)

    collaborator UNKNOWN
  • BMBF (German Ministry for Science)

    collaborator UNKNOWN
  • Deutsches Zentrum für Herz-Kreislauf-Forschung (DZHK)

    collaborator OTHER
  • Atrial Fibrillation Network

    lead OTHER

Principal Investigators

  • Paulus Kirchhof, MD · University of Birmingham Centre for Cardiovascular Sciences, Department of Cardiology, University Heart and Vascular Center UKE Hamburg, Hamburg, Germany

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-07-01
Primary Completion
2020-03-06
Completion
2020-05-31

Countries

  • Belgium
  • Czechia
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Poland
  • Spain
  • Switzerland
  • United Kingdom

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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 NCT01288352 on ClinicalTrials.gov