ID

39404

Description

Cardiac Rhythm Monitoring After Acute Decompensation for Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01216670

Link

https://clinicaltrials.gov/show/NCT01216670

Keywords

Versions (1)
  1. 1/8/20 1/8/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 8, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01216670

English

Eligibility Heart Failure NCT01216670

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject with a history of at least one heart failure (hf) hospitalization (as defined in the european society of cardiology or american college of cardiology/american heart association guidelines), emergency department (ed) visit, or urgent office visit necessitating intravenous (iv) diuretic or augmentation of oral diuretic, iv inotropic, or iv vasodilator or other hf parenteral therapy within 15 days prior to device implant
Description

Hospitalization Due to Heart Failure Quantity | Emergency department visit | Office Visits Urgent | Patient need for Diuretics Intravenous | Patient need for Oral Diuretic Therapy Augmentation | Patient need for Inotropic agent Intravenous | Patient need for Intravenous vasodilator | Patient need for Parenteral therapy Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3898876
UMLS CUI [1,2]
C1265611
UMLS CUI [2]
C0586082
UMLS CUI [3,1]
C0028900
UMLS CUI [3,2]
C0439609
UMLS CUI [4,1]
C0686904
UMLS CUI [4,2]
C0012798
UMLS CUI [4,3]
C1522726
UMLS CUI [5,1]
C0686904
UMLS CUI [5,2]
C3898091
UMLS CUI [6,1]
C0686904
UMLS CUI [6,2]
C0304509
UMLS CUI [6,3]
C1522726
UMLS CUI [7,1]
C0686904
UMLS CUI [7,2]
C0443081
UMLS CUI [8,1]
C0686904
UMLS CUI [8,2]
C0259961
UMLS CUI [8,3]
C0018801
subject has an implanted reveal® xt device (less than 15 days post implant);
Description

Implantable cardiac monitor Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C3879681
UMLS CUI [1,2]
C0205369
ejection fraction (ef) less than 40 percent
Description

Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0232174
patient with access to a telephone line
Description

Access to telephone

Data type

boolean

Alias
UMLS CUI [1]
C1822200
patient or the patient's caregiver is willing and able to use the medtronic carelink®
Description

Use of Software Specified | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C0037585
UMLS CUI [1,3]
C0205369
UMLS CUI [2]
C3846158
network monitor and to perform the required duties at home or has a family member or assistant perform those duties
Description

Use of Network Specified

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1882071
UMLS CUI [1,3]
C0205369
age greater than 18 years old
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient is willing and able to comply with the clinical investigation plan and willing to remain available for follow-up visit, through study closure
Description

Protocol Compliance | Patient Available Follow-up

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
patient (or patient's legally authorized representative) is willing and able to sign and date the study 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
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
new york heart association (nyha) class iv (chronic or ambulatory)
Description

New York Heart Association Classification chronic | New York Heart Association Classification Ambulatory

Data type

boolean

Alias
UMLS CUI [1,1]
C1275491
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1275491
UMLS CUI [2,2]
C1561561
planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
Description

Implantable defibrillator Planned | Artificial cardiac pacemaker Planned | Implantable defibrillator Previous | Artificial cardiac pacemaker Previous

Data type

boolean

Alias
UMLS CUI [1,1]
C0162589
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0030163
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0162589
UMLS CUI [3,2]
C0205156
UMLS CUI [4,1]
C0030163
UMLS CUI [4,2]
C0205156
patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
Description

Life Expectancy Due to Disease | Exception Cardiovascular Diseases

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007222
severe chronic obstructive pulmonary disorder (copd)
Description

Severe chronic obstructive pulmonary disease

Data type

boolean

Alias
UMLS CUI [1]
C0730607
chronic atrial fibrillation at time of enrollment
Description

Chronic atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C0694539
st segment elevation at time of electrocardiogram
Description

ST segment elevation ECG

Data type

boolean

Alias
UMLS CUI [1,1]
C0520886
UMLS CUI [1,2]
C0013798
cognitive disease
Description

Cognition Disorder

Data type

boolean

Alias
UMLS CUI [1]
C0009241
pregnancy or childbearing potential and not on reliable contraceptive
Description

Pregnancy | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2,1]
C3831118
UMLS CUI [2,2]
C0700589
UMLS CUI [2,3]
C0332197
anticipated compliance problem or participation in another competitive trial
Description

Poor compliance Anticipated | Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1,1]
C0032646
UMLS CUI [1,2]
C3840775
UMLS CUI [2]
C2348568
UMLS CUI [3]
C0008976
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Similar models

Eligibility Heart Failure NCT01216670

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hospitalization Due to Heart Failure Quantity | Emergency department visit | Office Visits Urgent | Patient need for Diuretics Intravenous | Patient need for Oral Diuretic Therapy Augmentation | Patient need for Inotropic agent Intravenous | Patient need for Intravenous vasodilator | Patient need for Parenteral therapy Heart failure
Item
subject with a history of at least one heart failure (hf) hospitalization (as defined in the european society of cardiology or american college of cardiology/american heart association guidelines), emergency department (ed) visit, or urgent office visit necessitating intravenous (iv) diuretic or augmentation of oral diuretic, iv inotropic, or iv vasodilator or other hf parenteral therapy within 15 days prior to device implant
boolean
C3898876 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
C0586082 (UMLS CUI [2])
C0028900 (UMLS CUI [3,1])
C0439609 (UMLS CUI [3,2])
C0686904 (UMLS CUI [4,1])
C0012798 (UMLS CUI [4,2])
C1522726 (UMLS CUI [4,3])
C0686904 (UMLS CUI [5,1])
C3898091 (UMLS CUI [5,2])
C0686904 (UMLS CUI [6,1])
C0304509 (UMLS CUI [6,2])
C1522726 (UMLS CUI [6,3])
C0686904 (UMLS CUI [7,1])
C0443081 (UMLS CUI [7,2])
C0686904 (UMLS CUI [8,1])
C0259961 (UMLS CUI [8,2])
C0018801 (UMLS CUI [8,3])
Implantable cardiac monitor Specified
Item
subject has an implanted reveal® xt device (less than 15 days post implant);
boolean
C3879681 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
Cardiac ejection fraction
Item
ejection fraction (ef) less than 40 percent
boolean
C0232174 (UMLS CUI [1])
Access to telephone
Item
patient with access to a telephone line
boolean
C1822200 (UMLS CUI [1])
Use of Software Specified | Other Coding
Item
patient or the patient's caregiver is willing and able to use the medtronic carelink®
boolean
C1524063 (UMLS CUI [1,1])
C0037585 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Use of Network Specified
Item
network monitor and to perform the required duties at home or has a family member or assistant perform those duties
boolean
C1524063 (UMLS CUI [1,1])
C1882071 (UMLS CUI [1,2])
C0205369 (UMLS CUI [1,3])
Age
Item
age greater than 18 years old
boolean
C0001779 (UMLS CUI [1])
Protocol Compliance | Patient Available Follow-up
Item
patient is willing and able to comply with the clinical investigation plan and willing to remain available for follow-up visit, through study closure
boolean
C0525058 (UMLS CUI [1])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Informed Consent | Informed Consent Patient Representative
Item
patient (or patient's legally authorized representative) is willing and able to sign and date the study informed consent
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Item Group
C0680251 (UMLS CUI)
New York Heart Association Classification chronic | New York Heart Association Classification Ambulatory
Item
new york heart association (nyha) class iv (chronic or ambulatory)
boolean
C1275491 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])
Implantable defibrillator Planned | Artificial cardiac pacemaker Planned | Implantable defibrillator Previous | Artificial cardiac pacemaker Previous
Item
planned or previous implant of implantable cardioverter-defibrillator or pacemaker device
boolean
C0162589 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0162589 (UMLS CUI [3,1])
C0205156 (UMLS CUI [3,2])
C0030163 (UMLS CUI [4,1])
C0205156 (UMLS CUI [4,2])
Life Expectancy Due to Disease | Exception Cardiovascular Diseases
Item
patient's life expectancy is less than one year due to non cardiovascular disorders, in the opinion of the physician
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
Severe chronic obstructive pulmonary disease
Item
severe chronic obstructive pulmonary disorder (copd)
boolean
C0730607 (UMLS CUI [1])
Chronic atrial fibrillation
Item
chronic atrial fibrillation at time of enrollment
boolean
C0694539 (UMLS CUI [1])
ST segment elevation ECG
Item
st segment elevation at time of electrocardiogram
boolean
C0520886 (UMLS CUI [1,1])
C0013798 (UMLS CUI [1,2])
Cognition Disorder
Item
cognitive disease
boolean
C0009241 (UMLS CUI [1])
Pregnancy | Childbearing Potential Contraceptive methods Absent
Item
pregnancy or childbearing potential and not on reliable contraceptive
boolean
C0032961 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Poor compliance Anticipated | Study Subject Participation Status | Clinical Trial
Item
anticipated compliance problem or participation in another competitive trial
boolean
C0032646 (UMLS CUI [1,1])
C3840775 (UMLS CUI [1,2])
C2348568 (UMLS CUI [2])
C0008976 (UMLS CUI [3])
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