ID

37522

Description

Diagnostic Device Risk Management of Atrial Fibrillation and Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01486316

Link

https://clinicaltrials.gov/show/NCT01486316

Keywords

Versions (1)
  1. 8/4/19 8/4/19 -
Copyright Holder

See clinicaltrials.gov

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August 4, 2019

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License

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01486316

English

Eligibility Atrial Fibrillation NCT01486316

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient is 18 years of age or older
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient (or patient's legally authorized representative) is willing and able to provide written informed consent
Description

Informed Consent | Informed Consent Patient Representative

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
patient is willing and able to comply with the protocol, including follow-up visits
Description

Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0525058
documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
Description

Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Suspicion Strong Atrial Fibrillation | Palpitations

Data type

boolean

Alias
UMLS CUI [1]
C0235480
UMLS CUI [2]
C2585653
UMLS CUI [3,1]
C0242114
UMLS CUI [3,2]
C0442821
UMLS CUI [3,3]
C0004238
UMLS CUI [4]
C0030252
patient is indicated for the reveal xt insertable cardiac monitor or other commercially-available and substantially equivalent medtronic insertable cardiac monitor
Description

Indication Implantable cardiac monitor Specified | Indication Implantable cardiac monitor Equivalent

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C3879681
UMLS CUI [1,3]
C0205369
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C3879681
UMLS CUI [2,3]
C0205163
recent hf event within prior 120 days (hf event defined as meeting any one of the following two criteria: 1. admission with primary diagnosis of hf 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of hf, emergency department, ambulance, observation unit, urgent care, hf/cardiology clinic, patient's home
Description

Heart failure Event Recent | Hospital admission Heart failure | Intravenous therapy Heart failure | Diuretics Intravenous | Intravenous vasodilator | Ultrafiltration | Hospital admission Secondary diagnosis Heart failure | Hospital admission Diagnosis Tertiary Heart failure | Emergency room admission | Ambulance | Observation unit | Urgent Care | Referral to heart failure clinic | Cardiology clinic | Home care of patient

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0441471
UMLS CUI [1,3]
C0332185
UMLS CUI [2,1]
C0184666
UMLS CUI [2,2]
C0018801
UMLS CUI [3,1]
C0455142
UMLS CUI [3,2]
C0018801
UMLS CUI [4,1]
C0012798
UMLS CUI [4,2]
C1522726
UMLS CUI [5]
C0443081
UMLS CUI [6]
C0041612
UMLS CUI [7,1]
C0184666
UMLS CUI [7,2]
C0332138
UMLS CUI [7,3]
C0018801
UMLS CUI [8,1]
C0184666
UMLS CUI [8,2]
C0011900
UMLS CUI [8,3]
C0205372
UMLS CUI [8,4]
C0018801
UMLS CUI [9]
C0583237
UMLS CUI [10]
C0002422
UMLS CUI [11]
C4284828
UMLS CUI [12]
C2362545
UMLS CUI [13]
C1277209
UMLS CUI [14]
C3810847
UMLS CUI [15]
C0204977
willing and able to transmit data via carelink
Description

Data Transmission Willing | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C0332289
UMLS CUI [1,2]
C0600109
UMLS CUI [2]
C3846158
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient is pregnant
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
patient has been participating in another study that may interfere with the identify-hf protocol required procedures
Description

Study Subject Participation Status Interferes with Study Protocol Procedures

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C2348563
UMLS CUI [1,4]
C0184661
endstage (stage d or new york heart association class iv) heart failure
Description

End stage cardiac failure | Heart failure Stage | Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1868938
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1306673
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C1275491
asymptomatic (stage b or new york heart association class i) heart failure
Description

Heart failure Asymptomatic Stage | Heart failure Asymptomatic New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231221
UMLS CUI [1,3]
C1306673
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0231221
UMLS CUI [2,3]
C1275491
severe aortic stenosis or insufficiency
Description

Aortic stenosis, severe | Aortic Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1]
C3806272
UMLS CUI [2,1]
C0003504
UMLS CUI [2,2]
C0205082
existing insertable cardiac monitor implanted for more than 1 year
Description

Implantable cardiac monitor insertion

Data type

boolean

Alias
UMLS CUI [1]
C3805086
existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
Description

Pulse Generator Present | Implantable cardioverter-defibrillator Present | Cardiac Resynchronization Therapy Device Present

Data type

boolean

Alias
UMLS CUI [1,1]
C1140627
UMLS CUI [1,2]
C0150312
UMLS CUI [2,1]
C0162589
UMLS CUI [2,2]
C0150312
UMLS CUI [3,1]
C2936377
UMLS CUI [3,2]
C0150312
severe renal impairment (estimated glomerular filtration rate <25ml/min)
Description

Renal Insufficiency Severe | Estimated Glomerular Filtration Rate

Data type

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C3811844
myocardial infarction within prior 30 days
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
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Similar models

Eligibility Atrial Fibrillation NCT01486316

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
patient is 18 years of age or older
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Informed Consent Patient Representative
Item
patient (or patient's legally authorized representative) is willing and able to provide written informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Protocol Compliance
Item
patient is willing and able to comply with the protocol, including follow-up visits
boolean
C0525058 (UMLS CUI [1])
Paroxysmal atrial fibrillation | Persistent atrial fibrillation | Suspicion Strong Atrial Fibrillation | Palpitations
Item
documented paroxysmal or persistent atrial fibrillation or strong suspicion of atrial fibrillation (i.e, palpitations)
boolean
C0235480 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
C0242114 (UMLS CUI [3,1])
C0442821 (UMLS CUI [3,2])
C0004238 (UMLS CUI [3,3])
C0030252 (UMLS CUI [4])
Indication Implantable cardiac monitor Specified | Indication Implantable cardiac monitor Equivalent
Item
patient is indicated for the reveal xt insertable cardiac monitor or other commercially-available and substantially equivalent medtronic insertable cardiac monitor
boolean
C3146298 (UMLS CUI [1,1])
C3879681 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C3879681 (UMLS CUI [2,2])
C0205163 (UMLS CUI [2,3])
Heart failure Event Recent | Hospital admission Heart failure | Intravenous therapy Heart failure | Diuretics Intravenous | Intravenous vasodilator | Ultrafiltration | Hospital admission Secondary diagnosis Heart failure | Hospital admission Diagnosis Tertiary Heart failure | Emergency room admission | Ambulance | Observation unit | Urgent Care | Referral to heart failure clinic | Cardiology clinic | Home care of patient
Item
recent hf event within prior 120 days (hf event defined as meeting any one of the following two criteria: 1. admission with primary diagnosis of hf 2. intravenous hf therapy (e.g. iv diuretics/vasodilators) or ultrafiltration at any one of the following settings: admission with secondary/tertiary diagnosis of hf, emergency department, ambulance, observation unit, urgent care, hf/cardiology clinic, patient's home
boolean
C0018801 (UMLS CUI [1,1])
C0441471 (UMLS CUI [1,2])
C0332185 (UMLS CUI [1,3])
C0184666 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0455142 (UMLS CUI [3,1])
C0018801 (UMLS CUI [3,2])
C0012798 (UMLS CUI [4,1])
C1522726 (UMLS CUI [4,2])
C0443081 (UMLS CUI [5])
C0041612 (UMLS CUI [6])
C0184666 (UMLS CUI [7,1])
C0332138 (UMLS CUI [7,2])
C0018801 (UMLS CUI [7,3])
C0184666 (UMLS CUI [8,1])
C0011900 (UMLS CUI [8,2])
C0205372 (UMLS CUI [8,3])
C0018801 (UMLS CUI [8,4])
C0583237 (UMLS CUI [9])
C0002422 (UMLS CUI [10])
C4284828 (UMLS CUI [11])
C2362545 (UMLS CUI [12])
C1277209 (UMLS CUI [13])
C3810847 (UMLS CUI [14])
C0204977 (UMLS CUI [15])
Data Transmission Willing | Other Coding
Item
willing and able to transmit data via carelink
boolean
C0332289 (UMLS CUI [1,1])
C0600109 (UMLS CUI [1,2])
C3846158 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Pregnancy
Item
patient is pregnant
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status Interferes with Study Protocol Procedures
Item
patient has been participating in another study that may interfere with the identify-hf protocol required procedures
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
End stage cardiac failure | Heart failure Stage | Heart failure New York Heart Association Classification
Item
endstage (stage d or new york heart association class iv) heart failure
boolean
C1868938 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C1275491 (UMLS CUI [3,2])
Heart failure Asymptomatic Stage | Heart failure Asymptomatic New York Heart Association Classification
Item
asymptomatic (stage b or new york heart association class i) heart failure
boolean
C0018801 (UMLS CUI [1,1])
C0231221 (UMLS CUI [1,2])
C1306673 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0231221 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
Aortic stenosis, severe | Aortic Insufficiency Severe
Item
severe aortic stenosis or insufficiency
boolean
C3806272 (UMLS CUI [1])
C0003504 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Implantable cardiac monitor insertion
Item
existing insertable cardiac monitor implanted for more than 1 year
boolean
C3805086 (UMLS CUI [1])
Pulse Generator Present | Implantable cardioverter-defibrillator Present | Cardiac Resynchronization Therapy Device Present
Item
existing implantable pulse generator, implantable cardioverter defibrillator, cardiac resynchronization therapy device
boolean
C1140627 (UMLS CUI [1,1])
C0150312 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0150312 (UMLS CUI [2,2])
C2936377 (UMLS CUI [3,1])
C0150312 (UMLS CUI [3,2])
Renal Insufficiency Severe | Estimated Glomerular Filtration Rate
Item
severe renal impairment (estimated glomerular filtration rate <25ml/min)
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3811844 (UMLS CUI [2])
Myocardial Infarction
Item
myocardial infarction within prior 30 days
boolean
C0027051 (UMLS CUI [1])
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