ID

37524

Beschrijving

Recording for Potential AF Drivers and Patient Specific Atrial Anatomy & Atrial Electrogram Maps; ODM derived from: https://clinicaltrials.gov/show/NCT01581437

Link

https://clinicaltrials.gov/show/NCT01581437

Trefwoorden

Versies (1)
  1. 04-08-19 04-08-19 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

4 augustus 2019

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01581437

Engels

Eligibility Atrial Fibrillation NCT01581437

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients at vcu medical center who are 21 years or older undergoing eps for ablation of persistent af (non-rheumatic) whose af episodes last equal to or greater than 7 days but terminate with dc cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
Beschrijving

Age | Electrophysiologic study | Ablation Persistent atrial fibrillation | Non-rheumatic atrial fibrillation | Atrial Fibrillation Episode Duration | Episode Ending Due to Direct current cardioversion | Episode Ending Due to Anti-Arrhythmia Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0199551
UMLS CUI [3,1]
C0547070
UMLS CUI [3,2]
C2585653
UMLS CUI [4]
C0340490
UMLS CUI [5,1]
C0004238
UMLS CUI [5,2]
C0332189
UMLS CUI [5,3]
C0449238
UMLS CUI [6,1]
C0332189
UMLS CUI [6,2]
C2746065
UMLS CUI [6,3]
C0678226
UMLS CUI [6,4]
C0542380
UMLS CUI [7,1]
C0332189
UMLS CUI [7,2]
C2746065
UMLS CUI [7,3]
C0678226
UMLS CUI [7,4]
C0003195
per current standard of care, af patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
Beschrijving

Standard of Care Atrial Fibrillation | Anti-Arrhythmia Agents Quantity failed | Qualification Ablation failed

Datatype

boolean

Alias
UMLS CUI [1,1]
C2936643
UMLS CUI [1,2]
C0004238
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C1265611
UMLS CUI [2,3]
C0231175
UMLS CUI [3,1]
C1709790
UMLS CUI [3,2]
C0547070
UMLS CUI [3,3]
C0231175
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
active coronary ischemic in the past year
Beschrijving

Coronary ischemic

Datatype

boolean

Alias
UMLS CUI [1]
C1394005
rheumatic valve disease, that leads to distinct af and increases thromboembolic risk
Beschrijving

Rheumatic disease of heart valve Resulting in Atrial Fibrillation | Rheumatic disease of heart valve Increases Thromboembolism Risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0264757
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0004238
UMLS CUI [2,1]
C0264757
UMLS CUI [2,2]
C0205217
UMLS CUI [2,3]
C0040038
UMLS CUI [2,4]
C0035647
prior ablation or cardiac surgery, that alters atrial electophysiology
Beschrijving

Ablation Changing Electrophysiology Atrial | Cardiac Surgery Changing Electrophysiology Atrial

Datatype

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0392747
UMLS CUI [1,3]
C0430467
UMLS CUI [1,4]
C0018792
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C0392747
UMLS CUI [2,3]
C0430467
UMLS CUI [2,4]
C0018792
left atrial clot or dense contrast on tee, which would increase thromboembolic risk
Beschrijving

Left atrium Clot Transesophageal Echocardiography | Increase Thromboembolism Risk

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C0302148
UMLS CUI [1,3]
C0206054
UMLS CUI [2,1]
C0442805
UMLS CUI [2,2]
C0040038
UMLS CUI [2,3]
C0035647
out of range serum electrolytes, including k outside 4.0-5.0 mmol/1
Beschrijving

Electrolyte abnormality serum | Potassium measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0541924
UMLS CUI [2]
C0202194
left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
Beschrijving

Left atrium Diameter Size

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225860
UMLS CUI [1,2]
C1301886
UMLS CUI [1,3]
C0456389
thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
Beschrijving

Thrombotic disease | Venous filter | Transient Ischemic Attack | Cerebrovascular accident

Datatype

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C4489431
UMLS CUI [3]
C0007787
UMLS CUI [4]
C0038454
pregnancy
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
inability or unwillingness to provide informed consent
Beschrijving

Informed Consent Unable | Informed Consent Unwilling

Datatype

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
unable to converse in english
Beschrijving

Conversation English Language Unable

Datatype

boolean

Alias
UMLS CUI [1,1]
C0871703
UMLS CUI [1,2]
C0376245
UMLS CUI [1,3]
C1299582
use of anti-arrhythmic drug less than 5 x half-life prior ablation or cardiac surgery, that alters atrial electophysiology
Beschrijving

Anti-Arrhythmia Agents prior to Ablation | Anti-Arrhythmia Agents prior to Cardiac Surgery

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003195
UMLS CUI [1,2]
C0332152
UMLS CUI [1,3]
C0547070
UMLS CUI [2,1]
C0003195
UMLS CUI [2,2]
C0332152
UMLS CUI [2,3]
C0018821
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Similar models

Eligibility Atrial Fibrillation NCT01581437

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age | Electrophysiologic study | Ablation Persistent atrial fibrillation | Non-rheumatic atrial fibrillation | Atrial Fibrillation Episode Duration | Episode Ending Due to Direct current cardioversion | Episode Ending Due to Anti-Arrhythmia Agents
Item
patients at vcu medical center who are 21 years or older undergoing eps for ablation of persistent af (non-rheumatic) whose af episodes last equal to or greater than 7 days but terminate with dc cardioversion or anti-arrhythmic drugs and do not recur within 24 hours.
boolean
C0001779 (UMLS CUI [1])
C0199551 (UMLS CUI [2])
C0547070 (UMLS CUI [3,1])
C2585653 (UMLS CUI [3,2])
C0340490 (UMLS CUI [4])
C0004238 (UMLS CUI [5,1])
C0332189 (UMLS CUI [5,2])
C0449238 (UMLS CUI [5,3])
C0332189 (UMLS CUI [6,1])
C2746065 (UMLS CUI [6,2])
C0678226 (UMLS CUI [6,3])
C0542380 (UMLS CUI [6,4])
C0332189 (UMLS CUI [7,1])
C2746065 (UMLS CUI [7,2])
C0678226 (UMLS CUI [7,3])
C0003195 (UMLS CUI [7,4])
Standard of Care Atrial Fibrillation | Anti-Arrhythmia Agents Quantity failed | Qualification Ablation failed
Item
per current standard of care, af patients must have failed equal to or greater than 1 anti-arrhythmic drug to qualify for ablation.
boolean
C2936643 (UMLS CUI [1,1])
C0004238 (UMLS CUI [1,2])
C0003195 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0231175 (UMLS CUI [2,3])
C1709790 (UMLS CUI [3,1])
C0547070 (UMLS CUI [3,2])
C0231175 (UMLS CUI [3,3])
Item Group
C0680251 (UMLS CUI)
Coronary ischemic
Item
active coronary ischemic in the past year
boolean
C1394005 (UMLS CUI [1])
Rheumatic disease of heart valve Resulting in Atrial Fibrillation | Rheumatic disease of heart valve Increases Thromboembolism Risk
Item
rheumatic valve disease, that leads to distinct af and increases thromboembolic risk
boolean
C0264757 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
C0264757 (UMLS CUI [2,1])
C0205217 (UMLS CUI [2,2])
C0040038 (UMLS CUI [2,3])
C0035647 (UMLS CUI [2,4])
Ablation Changing Electrophysiology Atrial | Cardiac Surgery Changing Electrophysiology Atrial
Item
prior ablation or cardiac surgery, that alters atrial electophysiology
boolean
C0547070 (UMLS CUI [1,1])
C0392747 (UMLS CUI [1,2])
C0430467 (UMLS CUI [1,3])
C0018792 (UMLS CUI [1,4])
C0018821 (UMLS CUI [2,1])
C0392747 (UMLS CUI [2,2])
C0430467 (UMLS CUI [2,3])
C0018792 (UMLS CUI [2,4])
Left atrium Clot Transesophageal Echocardiography | Increase Thromboembolism Risk
Item
left atrial clot or dense contrast on tee, which would increase thromboembolic risk
boolean
C0225860 (UMLS CUI [1,1])
C0302148 (UMLS CUI [1,2])
C0206054 (UMLS CUI [1,3])
C0442805 (UMLS CUI [2,1])
C0040038 (UMLS CUI [2,2])
C0035647 (UMLS CUI [2,3])
Electrolyte abnormality serum | Potassium measurement
Item
out of range serum electrolytes, including k outside 4.0-5.0 mmol/1
boolean
C0541924 (UMLS CUI [1])
C0202194 (UMLS CUI [2])
Left atrium Diameter Size
Item
left atrial diameter greater than 60 mm, to exclude extreme structural remodeling and failure to maintain sinus rhythm
boolean
C0225860 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
C0456389 (UMLS CUI [1,3])
Thrombotic disease | Venous filter | Transient Ischemic Attack | Cerebrovascular accident
Item
thrombotic disease, venous filters, transient ischemic attack or cerebrovascular accident, to minimize additional risk
boolean
C0040053 (UMLS CUI [1])
C4489431 (UMLS CUI [2])
C0007787 (UMLS CUI [3])
C0038454 (UMLS CUI [4])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Informed Consent Unable | Informed Consent Unwilling
Item
inability or unwillingness to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Conversation English Language Unable
Item
unable to converse in english
boolean
C0871703 (UMLS CUI [1,1])
C0376245 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Anti-Arrhythmia Agents prior to Ablation | Anti-Arrhythmia Agents prior to Cardiac Surgery
Item
use of anti-arrhythmic drug less than 5 x half-life prior ablation or cardiac surgery, that alters atrial electophysiology
boolean
C0003195 (UMLS CUI [1,1])
C0332152 (UMLS CUI [1,2])
C0547070 (UMLS CUI [1,3])
C0003195 (UMLS CUI [2,1])
C0332152 (UMLS CUI [2,2])
C0018821 (UMLS CUI [2,3])
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