ODM derived from

  1. 12/9/13 12/9/13 - Martin Dugas
Uploaded on:

December 9, 2013

To request one please log in.
License :
Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility NCT00408473 Atrial Fibrillation


  1. StudyEvent: Eligibility
    1. Eligibility
Inclusion Criteria
age 18 Years to 65 Years
History of first symptomatic & documented episode of AF
LVEF > 40% and not on AAD and in sinus rhythm at time of recruitment
Exclusion Criteria
History of more than 1 symptomatic documented AF episode, persistent or permanent AF.
History of ablation for previous AF
Reversible cause for AF (e.g.thyroid, alcohol, pulmonary embolism, surgery
Severe symptoms during AF episode (e.g.syncope, chest pain)
All types of treated arrhythmias other than AF
History of myocardial infarction (MI), coronary artery disease (CAD), heart failure (I, II, III and IV of New York Heart Association -NYHA- classification) or valvular diseases
LVEF - Left ventricular ejection fraction
Bradycardia < 40 beats/min and all ECG abnormalities: PR> 240ms or QRS> 120 ms or QTc> 440 ms
Brugada Syndrome (disorder)
Conduction disturbances: complete bundle branch block (LBBB) or (RBBB), bifascicular block
2nd or 3rd degree atrioventricular (AV) block
Coronary sinus rhythm disorder
Severe hypertension with:Systolic blood pressure >= 180 mmHg, and / or Diastolic blood pressure >= 100 mmHg
Left ventricular hypertrophy (LVH) with septal thickness > 14 mm on Echocardiogram
(Artificial) Cardiac pacemaker
Heart surgery within the last 6 months, or non-stable postoperative condition
Renal failure: serum creatinine >= 150 µmol/l or creatinine clearance <= 50 ml/min (Cockroft and Gault formula
Uncorrected electrolytic abnormalities
Have used recently in the last 3 months prior to the inclusion any of the following treatments: Oral amiodarone, Treatments that lengthen QT interval (e.g.Sultopride, Drugs causing torsades de pointe (e.g.mizolastine, pentamidine, sparfloxacin, moxifloxacin, Bupropion
Anti-hypertensive drugs other than permitted in the study: ACE-I, ARB (sartans) and DHP from Calcium channel blockers (CCB

Similar models

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial