ID

40359

Description

Ability of Home Monitoring® to Detect and Manage the Inappropriate Diagnoses in Implantable Cardioverter Defibrillators.; ODM derived from: https://clinicaltrials.gov/show/NCT01594112

Link

https://clinicaltrials.gov/show/NCT01594112

Keywords

Versions (1)
  1. 4/13/20 4/13/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

April 13, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility ICD NCT01594112

English

Eligibility ICD NCT01594112

1 forms  
  1. StudyEvent: Eligibility
    1. Eligibility ICD NCT01594112
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
subject implanted with a single, dual, or triple chambers icd within the last 3 months
Description

Implantable Cardioverter-Defibrillator Placement | Single-chamber implantable defibrillator | Dual-chamber implantable defibrillator | Other Coding

Data type

boolean

Alias
UMLS CUI [1]
C2825184
UMLS CUI [2]
C3881168
UMLS CUI [3]
C0494014
UMLS CUI [4]
C3846158
home monitoring® activated and functional since hospital discharge
Description

Patient Monitoring At home

Data type

boolean

Alias
UMLS CUI [1,1]
C0030695
UMLS CUI [1,2]
C4534363
patient willing and able to comply with the protocol and who has provided written informed consent about home monitoring®,
Description

Protocol Compliance | Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
patient whose medical situation is stable
Description

Patient's condition stable

Data type

boolean

Alias
UMLS CUI [1]
C1282982
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
icd replacements
Description

Implantable defibrillator replacement

Data type

boolean

Alias
UMLS CUI [1]
C1112389
new york heart association function class iv patients
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
pregnant women or women who plan to become pregnant during the trial
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc.
Description

Disease Associated with Life Expectancy Reduced | Exception Heart Diseases | Malignant Neoplasms | Uremia | Urea measurement | Creatinine measurement, serum | Liver Failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0012634
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0023671
UMLS CUI [1,4]
C0392756
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
UMLS CUI [3]
C0006826
UMLS CUI [4]
C0041948
UMLS CUI [5]
C0523961
UMLS CUI [6]
C0201976
UMLS CUI [7]
C0085605
age < 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
patient unable to handle the biotronik's transmitter correctly
Description

Use of Transmitter Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C1524063
UMLS CUI [1,2]
C1707723
UMLS CUI [1,3]
C1299582
change of residence expected during the study
Description

Relocation of home Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C2699029
UMLS CUI [1,2]
C1517001
insufficient global system for mobile communication (gsm) coverage at patient's home
Description

Communication Mobile Insufficient

Data type

boolean

Alias
UMLS CUI [1,1]
C0009452
UMLS CUI [1,2]
C0231435
UMLS CUI [1,3]
C0231180
participation in another clinical study
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility ICD NCT01594112

1 forms
  1. StudyEvent: Eligibility
    1. Eligibility ICD NCT01594112
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantable Cardioverter-Defibrillator Placement | Single-chamber implantable defibrillator | Dual-chamber implantable defibrillator | Other Coding
Item
subject implanted with a single, dual, or triple chambers icd within the last 3 months
boolean
C2825184 (UMLS CUI [1])
C3881168 (UMLS CUI [2])
C0494014 (UMLS CUI [3])
C3846158 (UMLS CUI [4])
Patient Monitoring At home
Item
home monitoring® activated and functional since hospital discharge
boolean
C0030695 (UMLS CUI [1,1])
C4534363 (UMLS CUI [1,2])
Protocol Compliance | Informed Consent
Item
patient willing and able to comply with the protocol and who has provided written informed consent about home monitoring®,
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Patient's condition stable
Item
patient whose medical situation is stable
boolean
C1282982 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Implantable defibrillator replacement
Item
icd replacements
boolean
C1112389 (UMLS CUI [1])
New York Heart Association Classification
Item
new york heart association function class iv patients
boolean
C1275491 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned
Item
pregnant women or women who plan to become pregnant during the trial
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Disease Associated with Life Expectancy Reduced | Exception Heart Diseases | Malignant Neoplasms | Uremia | Urea measurement | Creatinine measurement, serum | Liver Failure
Item
presence of any disease, other than patient's cardiac disease, associated with reduced likelihood of survival for the duration of the trial, e.g. cancer, uraemia (urea > 70mg/dl or creatinine >3mg/dl), liver failure, etc.
boolean
C0012634 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C0392756 (UMLS CUI [1,4])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
C0006826 (UMLS CUI [3])
C0041948 (UMLS CUI [4])
C0523961 (UMLS CUI [5])
C0201976 (UMLS CUI [6])
C0085605 (UMLS CUI [7])
Age
Item
age < 18 years
boolean
C0001779 (UMLS CUI [1])
Use of Transmitter Unable
Item
patient unable to handle the biotronik's transmitter correctly
boolean
C1524063 (UMLS CUI [1,1])
C1707723 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Relocation of home Expected
Item
change of residence expected during the study
boolean
C2699029 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Communication Mobile Insufficient
Item
insufficient global system for mobile communication (gsm) coverage at patient's home
boolean
C0009452 (UMLS CUI [1,1])
C0231435 (UMLS CUI [1,2])
C0231180 (UMLS CUI [1,3])
Study Subject Participation Status | Clinical Trial
Item
participation in another clinical study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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