Early Treatment of Atrial Fibrillation for Stroke Prevention Trial
NCT01288352 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 2789
Last updated 2020-07-23
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
- collaborator INDUSTRY
- 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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