ID

37481

Description

Pacemaker Holter Assessment of the Effect of BMS-914392 on Atrial Fibrillation Burden; ODM derived from: https://clinicaltrials.gov/show/NCT01356914

Link

https://clinicaltrials.gov/show/NCT01356914

Keywords

Versions (1)
  1. 8/1/19 8/1/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 1, 2019

DOI

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01356914

English

Eligibility Atrial Fibrillation NCT01356914

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
paroxysmal atrial fibrillation (af)
Description

Paroxysmal atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0235480
programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
Description

Dual Chamber Pacemaker | Arrhythmia Diagnostic Appropriate

Data type

boolean

Alias
UMLS CUI [1]
C2911683
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0011900
UMLS CUI [2,3]
C1548787
1-50% af burden on pacemaker interrogation at screening.
Description

Atrial Fibrillation Percentage Artificial cardiac pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0030163
women of childbearing potential (wocbp) and men must be using an acceptable method of contraception to avoid pregnancy.
Description

Childbearing Potential Contraceptive methods | Gender Contraceptive methods

Data type

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
UMLS CUI [2,1]
C0079399
UMLS CUI [2,2]
C0700589
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent or permanent af.
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
af burden <1% or > 50%.
Description

Atrial Fibrillation Percentage

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0439165
current or history of neurological diseases and mental disorders.
Description

Nervous system disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
ejection fraction < 45%.
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
severe mitral or aortic valve dysfunction.
Description

Mitral Valve Dysfunction Severe | Aortic valve Dysfunction Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0026264
UMLS CUI [1,2]
C3887504
UMLS CUI [1,3]
C0205082
UMLS CUI [2,1]
C0003501
UMLS CUI [2,2]
C3887504
UMLS CUI [2,3]
C0205082
tia (transient ischemic attack) within last 12 months.
Description

Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0007787
acute coronary syndrome in the last 2 months.
Description

Acute Coronary Syndrome

Data type

boolean

Alias
UMLS CUI [1]
C0948089
previous af ablation.
Description

Catheter ablation for atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2702800
cardioversion in last 3 months.
Description

Electric Countershock

Data type

boolean

Alias
UMLS CUI [1]
C0013778
current kidney or liver disease, or current cancer.
Description

Kidney Disease | Liver disease | Malignant Neoplasms

Data type

boolean

Alias
UMLS CUI [1]
C0022658
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0006826
history of neurological and mental disorders.
Description

Nervous system disorder | Mental disorders

Data type

boolean

Alias
UMLS CUI [1]
C0027765
UMLS CUI [2]
C0004936
major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
Description

Major surgery | Cardiac Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0679637
UMLS CUI [2]
C0018821
screening lab test results outside of allowed limits per protocol.
Description

Laboratory Results Inconsistent Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C0442809
UMLS CUI [1,3]
C2348563
qtcf > 450 msec.
Description

QTcF - Fridericia's Correction Formula

Data type

boolean

Alias
UMLS CUI [1]
C1882513
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Similar models

Eligibility Atrial Fibrillation NCT01356914

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Paroxysmal atrial fibrillation
Item
paroxysmal atrial fibrillation (af)
boolean
C0235480 (UMLS CUI [1])
Dual Chamber Pacemaker | Arrhythmia Diagnostic Appropriate
Item
programmable dual chamber pacemaker with appropriate arrhythmia diagnostics.
boolean
C2911683 (UMLS CUI [1])
C0003811 (UMLS CUI [2,1])
C0011900 (UMLS CUI [2,2])
C1548787 (UMLS CUI [2,3])
Atrial Fibrillation Percentage Artificial cardiac pacemaker
Item
1-50% af burden on pacemaker interrogation at screening.
boolean
C0004238 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0030163 (UMLS CUI [1,3])
Childbearing Potential Contraceptive methods | Gender Contraceptive methods
Item
women of childbearing potential (wocbp) and men must be using an acceptable method of contraception to avoid pregnancy.
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0079399 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
persistent or permanent af.
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Atrial Fibrillation Percentage
Item
af burden <1% or > 50%.
boolean
C0004238 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
Nervous system disorder | Mental disorders
Item
current or history of neurological diseases and mental disorders.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Cardiac ejection fraction
Item
ejection fraction < 45%.
boolean
C0232174 (UMLS CUI [1])
Mitral Valve Dysfunction Severe | Aortic valve Dysfunction Severe
Item
severe mitral or aortic valve dysfunction.
boolean
C0026264 (UMLS CUI [1,1])
C3887504 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
C0003501 (UMLS CUI [2,1])
C3887504 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
Transient Ischemic Attack
Item
tia (transient ischemic attack) within last 12 months.
boolean
C0007787 (UMLS CUI [1])
Acute Coronary Syndrome
Item
acute coronary syndrome in the last 2 months.
boolean
C0948089 (UMLS CUI [1])
Catheter ablation for atrial fibrillation
Item
previous af ablation.
boolean
C2702800 (UMLS CUI [1])
Electric Countershock
Item
cardioversion in last 3 months.
boolean
C0013778 (UMLS CUI [1])
Kidney Disease | Liver disease | Malignant Neoplasms
Item
current kidney or liver disease, or current cancer.
boolean
C0022658 (UMLS CUI [1])
C0023895 (UMLS CUI [2])
C0006826 (UMLS CUI [3])
Nervous system disorder | Mental disorders
Item
history of neurological and mental disorders.
boolean
C0027765 (UMLS CUI [1])
C0004936 (UMLS CUI [2])
Major surgery | Cardiac Surgery
Item
major surgery within 4 weeks of first dose (cardiac surgery within 4 months).
boolean
C0679637 (UMLS CUI [1])
C0018821 (UMLS CUI [2])
Laboratory Results Inconsistent Study Protocol
Item
screening lab test results outside of allowed limits per protocol.
boolean
C1254595 (UMLS CUI [1,1])
C0442809 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
QTcF - Fridericia's Correction Formula
Item
qtcf > 450 msec.
boolean
C1882513 (UMLS CUI [1])
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