ID

39401

Beskrivning

INvestigation on Routine Follow-up in CONgestive HearT FAilure Patients With Remotely Monitored Implanted Cardioverter Defibrillators (ICD) SysTems; ODM derived from: https://clinicaltrials.gov/show/NCT01200381

Länk

https://clinicaltrials.gov/show/NCT01200381

Nyckelord

  1. 2020-01-08 2020-01-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 januari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01200381

Eligibility Heart Failure NCT01200381

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
indication for implantation (new, boxchange, upgrade) of icd/ crt-d
Beskrivning

Indication ICD Placement | Indication Implantation of CRT-D

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C2825184
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
written informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
ejection fraction <= 35%
Beskrivning

Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
new york heart association (nyha) class i-iii
Beskrivning

New York Heart Association Classification

Datatyp

boolean

Alias
UMLS CUI [1]
C1275491
age >=18 and <=80 years
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
in patient's home environment sufficient infrastructure (analog phone line or sufficient strength of gsm (global system for mobile communication) mobile phone network) for running a merlin@home transmitter is available
Beskrivning

Availability of Mobile Phone Network

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0470187
UMLS CUI [1,2]
C1136360
UMLS CUI [1,3]
C1882071
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
arterio ventricular (av) block iii / av block ii type mobitz
Beskrivning

Complete atrioventricular block | Mobitz type II atrioventricular block

Datatyp

boolean

Alias
UMLS CUI [1]
C0151517
UMLS CUI [2]
C0155700
severe renal insufficiency
Beskrivning

Renal Insufficiency Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1565489
UMLS CUI [1,2]
C0205082
coronary angiology intervention within previous 3 months
Beskrivning

Coronary angiography

Datatyp

boolean

Alias
UMLS CUI [1]
C0085532
myocardial infarction within previous month
Beskrivning

Myocardial Infarction

Datatyp

boolean

Alias
UMLS CUI [1]
C0027051
life expectancy < 1 year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
expected poor data quality / compliance
Beskrivning

Data Quality Poor Expected | Poor compliance Expected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0242483
UMLS CUI [1,2]
C0542537
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C0032646
UMLS CUI [2,2]
C1517001
pregnancy
Beskrivning

Pregnancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
patient is already participating to another study with active therapy arm
Beskrivning

Study Subject Participation Status | Clinical Trial Treatment Arm

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C1522541

Similar models

Eligibility Heart Failure NCT01200381

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication ICD Placement | Indication Implantation of CRT-D
Item
indication for implantation (new, boxchange, upgrade) of icd/ crt-d
boolean
C3146298 (UMLS CUI [1,1])
C2825184 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
Informed Consent
Item
written informed consent
boolean
C0021430 (UMLS CUI [1])
Cardiac ejection fraction
Item
ejection fraction <= 35%
boolean
C0232174 (UMLS CUI [1])
New York Heart Association Classification
Item
new york heart association (nyha) class i-iii
boolean
C1275491 (UMLS CUI [1])
Age
Item
age >=18 and <=80 years
boolean
C0001779 (UMLS CUI [1])
Availability of Mobile Phone Network
Item
in patient's home environment sufficient infrastructure (analog phone line or sufficient strength of gsm (global system for mobile communication) mobile phone network) for running a merlin@home transmitter is available
boolean
C0470187 (UMLS CUI [1,1])
C1136360 (UMLS CUI [1,2])
C1882071 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Complete atrioventricular block | Mobitz type II atrioventricular block
Item
arterio ventricular (av) block iii / av block ii type mobitz
boolean
C0151517 (UMLS CUI [1])
C0155700 (UMLS CUI [2])
Renal Insufficiency Severe
Item
severe renal insufficiency
boolean
C1565489 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Coronary angiography
Item
coronary angiology intervention within previous 3 months
boolean
C0085532 (UMLS CUI [1])
Myocardial Infarction
Item
myocardial infarction within previous month
boolean
C0027051 (UMLS CUI [1])
Life Expectancy
Item
life expectancy < 1 year
boolean
C0023671 (UMLS CUI [1])
Data Quality Poor Expected | Poor compliance Expected
Item
expected poor data quality / compliance
boolean
C0242483 (UMLS CUI [1,1])
C0542537 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0032646 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Study Subject Participation Status | Clinical Trial Treatment Arm
Item
patient is already participating to another study with active therapy arm
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1522541 (UMLS CUI [2,2])

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