ID

15201

Description

Clinical Investigation on Differences in the Magnitude of CRT Response in WOmen Versus MEN; ODM derived from: https://clinicaltrials.gov/show/NCT02344420

Link

https://clinicaltrials.gov/show/NCT02344420

Keywords

Versions (1)
  1. 5/22/16 5/22/16 -
Uploaded on

May 22, 2016

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02344420

English

Eligibility Heart Failure NCT02344420

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
indication for a "de novo" implantation of a crt device according to esc guidelines
Description

Indication Implantation de novo Cardiac Resynchronization Therapy Devices

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C1515568
UMLS CUI [1,4]
C2936377
understand the nature of the procedure
Description

Comprehension Study Protocol

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C2348563
give written informed consent
Description

Informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
crt device replacements
Description

Replacement Cardiac Resynchronization Therapy Devices

Data type

boolean

Alias
UMLS CUI [1,1]
C0035139
UMLS CUI [1,2]
C2936377
crt upgrades
Description

Upgrade to Cardiac Resynchronization Therapy Device

Data type

boolean

Alias
UMLS CUI [1,1]
C3272274
UMLS CUI [1,2]
C2936377
permanent / persistent atrial fibrillation
Description

Permanent atrial fibrillation | Persistent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
UMLS CUI [2]
C2585653
age< 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnant and breastfeeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
subjects with irreversible brain damage from pre existing cerebral disease
Description

Brain damage caused by Cerebral disorder Pre-existing

Data type

boolean

Alias
UMLS CUI [1,1]
C0270611
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0234387
UMLS CUI [1,4]
C2347662
subjects with acutely de compensated heart failure
Description

ADHF

Data type

boolean

Alias
UMLS CUI [1]
C1609524
nyha class iv heart failure
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
heart transplantation six months prior to the enrolment or expected within next 3 months.
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
Description

Cardiac Surgery | Planned Cardiac Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
have a life expectancy of less than 12 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
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Similar models

Eligibility Heart Failure NCT02344420

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation de novo Cardiac Resynchronization Therapy Devices
Item
indication for a "de novo" implantation of a crt device according to esc guidelines
boolean
C3146298 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C1515568 (UMLS CUI [1,3])
C2936377 (UMLS CUI [1,4])
Comprehension Study Protocol
Item
understand the nature of the procedure
boolean
C0162340 (UMLS CUI [1,1])
C2348563 (UMLS CUI [1,2])
Informed consent
Item
give written informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Replacement Cardiac Resynchronization Therapy Devices
Item
crt device replacements
boolean
C0035139 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Upgrade to Cardiac Resynchronization Therapy Device
Item
crt upgrades
boolean
C3272274 (UMLS CUI [1,1])
C2936377 (UMLS CUI [1,2])
Permanent atrial fibrillation | Persistent atrial fibrillation
Item
permanent / persistent atrial fibrillation
boolean
C2586056 (UMLS CUI [1])
C2585653 (UMLS CUI [2])
Age
Item
age< 18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant and breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Brain damage caused by Cerebral disorder Pre-existing
Item
subjects with irreversible brain damage from pre existing cerebral disease
boolean
C0270611 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0234387 (UMLS CUI [1,3])
C2347662 (UMLS CUI [1,4])
ADHF
Item
subjects with acutely de compensated heart failure
boolean
C1609524 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class iv heart failure
boolean
C1275491 (UMLS CUI [1])
Heart Transplantation
Item
heart transplantation six months prior to the enrolment or expected within next 3 months.
boolean
C0018823 (UMLS CUI [1])
Cardiac Surgery | Planned Cardiac Surgery
Item
cardiac surgery 3 months prior to the enrolment or planned within next 3 months.
boolean
C0018821 (UMLS CUI [1])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Life Expectancy
Item
have a life expectancy of less than 12 months
boolean
C0023671 (UMLS CUI [1])
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