Atrial Fibrillation ECG | Heart Valve Involvement Absent | Indication Catheter ablation
Item
i1. non-valvular af (ecg-documented) with a clinical indication for catheter ablation
boolean
C0004238 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
C0018826 (UMLS CUI [2,1])
C1314939 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C3146298 (UMLS CUI [3,1])
C0162563 (UMLS CUI [3,2])
Indication Catheter ablation | Anticoagulant therapy
Item
i2. clinical indication to undergo catheter ablation on continuous anticoagulant therapy
boolean
C3146298 (UMLS CUI [1,1])
C0162563 (UMLS CUI [1,2])
C0150457 (UMLS CUI [2])
Cerebrovascular accident Risk factors Quantity CHADS2 score
Item
i3. presence of at least one of the chads2 stroke risk factors
boolean
C0038454 (UMLS CUI [1,1])
C0035648 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C2585876 (UMLS CUI [1,4])
Cerebrovascular accident | Transient Ischemic Attack
Item
stroke or tia
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Age
Item
age ≥ 75 years,
boolean
C0001779 (UMLS CUI [1])
Hypertensive disease | Treatment chronic Hypertensive disease | Patient need for Antihypertensive therapy Continuous | Blood pressure Resting
Item
hypertension, defined as chronic treatment for hypertension, estimated need for continuous antihypertensive therapy or resting blood pressure > 145/90 mm hg,
boolean
C0020538 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
C0020538 (UMLS CUI [2,3])
C0686904 (UMLS CUI [3,1])
C0585941 (UMLS CUI [3,2])
C0549178 (UMLS CUI [3,3])
C1271104 (UMLS CUI [4,1])
C0035253 (UMLS CUI [4,2])
Diabetes Mellitus
Item
diabetes mellitus,
boolean
C0011849 (UMLS CUI [1])
Heart failure Symptomatic New York Heart Association Classification
Item
symptomatic heart failure (nyha ≥ ii).
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Age
Item
i4. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Informed Consent
Item
i5. provision of signed informed consent
boolean
C0021430 (UMLS CUI [1])
Exclusion Criteria General
Item
general exclusion criteria
boolean
C0680251 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
Disease Limiting Life Expectancy
Item
e1. any disease that limits life expectancy to less than 1 year
boolean
C0012634 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
Study Subject Participation Status
Item
e2. participation in another clinical trial, either within the past two months or still ongoing
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Specified
Item
e3. previous participation in axafa
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0205369 (UMLS CUI [2,2])
Pregnancy | Childbearing Potential Contraceptive methods Absent | Exception Gender Contraceptive methods | Exception Oral contraception | Exception Intrauterine Devices | Exception Female sterility
Item
e4. pregnant women or women of childbearing potential not on adequate birth control: only women with a highly effective method of contraception (oral contraception or intra-uterine device) or sterile women can be randomised.
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
C1705847 (UMLS CUI [3,1])
C0079399 (UMLS CUI [3,2])
C0700589 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C0029151 (UMLS CUI [4,2])
C1705847 (UMLS CUI [5,1])
C0021900 (UMLS CUI [5,2])
C1705847 (UMLS CUI [6,1])
C0917730 (UMLS CUI [6,2])
Breast Feeding
Item
e5. breastfeeding women
boolean
C0006147 (UMLS CUI [1])
Substance Use Disorders
Item
e6. drug abuse or clinically manifest alcohol abuse
boolean
C0038586 (UMLS CUI [1])
Cerebrovascular accident
Item
e7. any stroke within 14 days before randomisation
boolean
C0038454 (UMLS CUI [1])
Exclusion Criteria Relationship Cardiac problem
Item
exclusion criteria related to a cardiac condition
boolean
C0680251 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0262402 (UMLS CUI [1,3])
Atrial Fibrillation Valve | Mitral Valve Stenosis Severe | Mechanical heart valve | Mitral valvuloplasty
Item
e8. valvular af (as defined by the focussed update of the esc guidelines on af, i.e. severe mitral valve stenosis, mechanical heart valve). furthermore, patients who underwent mitral valve repair are not eligible for axafa.
boolean
C0004238 (UMLS CUI [1,1])
C1186983 (UMLS CUI [1,2])
C0026269 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0493527 (UMLS CUI [3])
C0396849 (UMLS CUI [4])
Catheter ablation for atrial fibrillation Previous | Operative Surgical Procedures Previous Atrial Fibrillation
Item
e9. any previous ablation or surgical therapy for af
boolean
C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])
Cardiac ablation Indication Any
Item
e10. cardiac ablation therapy for any indication (catheter-based or surgical) within 3 months prior to randomisation
boolean
C0162563 (UMLS CUI [1,1])
C3146298 (UMLS CUI [1,2])
C1552551 (UMLS CUI [1,3])
Patient need for Combined Modality Therapy | Clopidogrel | Aspirin | Oral anticoagulants
Item
e11. clinical need for "triple therapy" (combination therapy of clopidogrel, acetylsalicylic acid, and oral anticoagulation)
boolean
C0686904 (UMLS CUI [1,1])
C0009429 (UMLS CUI [1,2])
C0070166 (UMLS CUI [2])
C0004057 (UMLS CUI [3])
C0354604 (UMLS CUI [4])
Medical contraindication Vitamin K Antagonist | Medical contraindication Apixaban
Item
e12. other contraindications for use of vka or apixaban
boolean
C1301624 (UMLS CUI [1,1])
C2267235 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C1831808 (UMLS CUI [2,2])
Exclusion Criteria Relationship Laboratory test result abnormal
Item
exclusion criteria based on laboratory abnormalities
boolean
C0680251 (UMLS CUI [1,1])
C0439849 (UMLS CUI [1,2])
C0438215 (UMLS CUI [1,3])
Chronic Kidney Disease Severe | Estimated Glomerular Filtration Rate
Item
e13. severe chronic kidney disease with an estimated glomerular filtration rate (gfr) < 15 ml/min
boolean
C1561643 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])