Permanent atrial fibrillation
Item
permanent af defined by the presence of all of the following criteria:
boolean
C2586056 (UMLS CUI [1])
Atrial Fibrillation 12 lead ECG | Atrial Flutter 12 lead ECG
Item
availability of one 12-lead ecg not more than 14 days prior to randomization showing that the patient is in af or atrial flutter;
boolean
C0004238 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
C0004239 (UMLS CUI [2,1])
C0430456 (UMLS CUI [2,2])
Atrial Fibrillation Disease length Documentation | Atrial Flutter Disease length Documentation | Atrial Fibrillation Disease length ECG rhythm strip | Atrial Flutter Disease length ECG rhythm strip
Item
availability of documentation (including either rhythm strips or medical report of the rhythm) showing that the patient was in af or atrial flutter at least 6 months prior to randomization;
boolean
C0004238 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
C0920316 (UMLS CUI [1,3])
C0004239 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0920316 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0872146 (UMLS CUI [3,2])
C2022160 (UMLS CUI [3,3])
C0004239 (UMLS CUI [4,1])
C0872146 (UMLS CUI [4,2])
C2022160 (UMLS CUI [4,3])
Sinus rhythm Absent
Item
no evidence of sinus rhythm in the period between these two documentations of af;
boolean
C0232201 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Atrial Fibrillation Continue allowed | Lacking Attempt Restore Sinus rhythm
Item
decision of the patient and physician to allow af to continue without further efforts to restore sinus rhythm.
boolean
C0004238 (UMLS CUI [1,1])
C0549178 (UMLS CUI [1,2])
C0683607 (UMLS CUI [1,3])
C0332268 (UMLS CUI [2,1])
C1516084 (UMLS CUI [2,2])
C1283255 (UMLS CUI [2,3])
C0232201 (UMLS CUI [2,4])
Risk Criteria Quantity
Item
at least one of the following risk criteria:
boolean
C0035647 (UMLS CUI [1,1])
C0243161 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Coronary Artery Disease
Item
coronary artery disease;
boolean
C1956346 (UMLS CUI [1])
Cerebrovascular accident | Transient Ischemic Attack
Item
prior stroke or transient ischemic attack [tia];
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Heart failure Symptomatic
Item
symptomatic heart failure;
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction [lvef] less or equal to 0.40;
boolean
C0428772 (UMLS CUI [1])
Peripheral arterial occlusive disease
Item
peripheral arterial occlusive disease;
boolean
C1306889 (UMLS CUI [1])
Age | Hypertensive disease | Diabetes Mellitus
Item
aged 75 years or older with both hypertension and diabetes mellitus.
boolean
C0001779 (UMLS CUI [1])
C0020538 (UMLS CUI [2])
C0011849 (UMLS CUI [3])
Paroxysmal atrial fibrillation
Item
paroxysmal af;
boolean
C0235480 (UMLS CUI [1])
Persistent atrial fibrillation | Decision Absent | Atrial Fibrillation Continue allowing | Lacking Attempt Restore Sinus rhythm
Item
persistent af without a decision to allow af to continue without further efforts to restore sinus rhythm;
boolean
C2585653 (UMLS CUI [1])
C0679006 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0004238 (UMLS CUI [3,1])
C0549178 (UMLS CUI [3,2])
C0683607 (UMLS CUI [3,3])
C0332268 (UMLS CUI [4,1])
C1516084 (UMLS CUI [4,2])
C1283255 (UMLS CUI [4,3])
C0232201 (UMLS CUI [4,4])
Heart failure New York Heart Association Classification | Heart failure Unstable New York Heart Association Classification
Item
heart failure of new-york heart association [nyha] class iv or recent unstable nyha class iii.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Study Subject Participation Status Considerations Additional
Item
the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
boolean
C2348568 (UMLS CUI [1,1])
C0518609 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])