ID

39602

Description

LV Endocardial Cardiac Resynchronisation Therapy; ODM derived from: https://clinicaltrials.gov/show/NCT02174289

Link

https://clinicaltrials.gov/show/NCT02174289

Keywords

  1. 2/2/20 2/2/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

February 2, 2020

DOI

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License

Creative Commons BY 4.0

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Eligibility Heart Failure NCT02174289

Eligibility Heart Failure NCT02174289

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
age greater than 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
nyha class ii-iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
lvef ≤35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
qrs ≥120 milliseconds
Description

QRS duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
optimal tolerated medical therapy
Description

Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
either unable to position an lv lead via the standard coronary sinus on crt implantation
Description

Implantation of CRT-D Problem

Data type

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0033213
or recipient of a crt-p or crt-d system for greater than 6 months for standard indications and limited improvement or worsened clinical status despite device optimisation
Description

Cardiac Resynchronization Therapy Pacemaker (CRT-P) Recipient | CRT-D Recipient

Data type

boolean

Alias
UMLS CUI [1,1]
C1737639
UMLS CUI [1,2]
C1709854
UMLS CUI [2,1]
C1135480
UMLS CUI [2,2]
C1709854
informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
Description

Life Expectancy Due to Comorbidity | Exception Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0009488
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007222
previous atrial septal defect device closure.
Description

Atrial septal defect closure device

Data type

boolean

Alias
UMLS CUI [1]
C2825201
chronic renal dialysis and end stage liver disease
Description

Dialysis chronic | End Stage Liver Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0011946
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0745744
history of stroke, myocardial infarction, unstable angina, coronary artery bypass grafting and coronary stenting within the last 3 months
Description

Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Coronary stenting

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0010055
UMLS CUI [5]
C0687568
presence of correctable valvular disease (aortic/mitral)
Description

Valvular disease | Aortic valve disorder | Diseases of mitral valve

Data type

boolean

Alias
UMLS CUI [1]
C3258293
UMLS CUI [2]
C1260873
UMLS CUI [3]
C0026265
mitral valve prosthesis.
Description

Mitral valve prosthesis

Data type

boolean

Alias
UMLS CUI [1]
C0182494
contra indication to vitamin k antagonist
Description

Medical contraindication Vitamin K Antagonist

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C2267235
unresolved intra-cardiac thrombus
Description

Resolution Lacking Intracardiac thrombus

Data type

boolean

Alias
UMLS CUI [1,1]
C1514893
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0876998
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Heart Failure NCT02174289

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
age greater than 18 years
boolean
C0001779 (UMLS CUI [1])
New York Heart Association Classification
Item
nyha class ii-iv
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef ≤35%
boolean
C0428772 (UMLS CUI [1])
QRS duration
Item
qrs ≥120 milliseconds
boolean
C0429025 (UMLS CUI [1])
Therapy Optimal
Item
optimal tolerated medical therapy
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Implantation of CRT-D Problem
Item
either unable to position an lv lead via the standard coronary sinus on crt implantation
boolean
C1135480 (UMLS CUI [1,1])
C0033213 (UMLS CUI [1,2])
Cardiac Resynchronization Therapy Pacemaker (CRT-P) Recipient | CRT-D Recipient
Item
or recipient of a crt-p or crt-d system for greater than 6 months for standard indications and limited improvement or worsened clinical status despite device optimisation
boolean
C1737639 (UMLS CUI [1,1])
C1709854 (UMLS CUI [1,2])
C1135480 (UMLS CUI [2,1])
C1709854 (UMLS CUI [2,2])
Informed Consent
Item
informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life Expectancy Due to Comorbidity | Exception Cardiovascular Disease
Item
life-expectancy less than 1 year due to concomitant, non-cardiovascular disorders
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0009488 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0007222 (UMLS CUI [2,2])
Atrial septal defect closure device
Item
previous atrial septal defect device closure.
boolean
C2825201 (UMLS CUI [1])
Dialysis chronic | End Stage Liver Disease
Item
chronic renal dialysis and end stage liver disease
boolean
C0011946 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0745744 (UMLS CUI [2])
Cerebrovascular accident | Myocardial Infarction | Angina, Unstable | Coronary Artery Bypass Surgery | Coronary stenting
Item
history of stroke, myocardial infarction, unstable angina, coronary artery bypass grafting and coronary stenting within the last 3 months
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C0687568 (UMLS CUI [5])
Valvular disease | Aortic valve disorder | Diseases of mitral valve
Item
presence of correctable valvular disease (aortic/mitral)
boolean
C3258293 (UMLS CUI [1])
C1260873 (UMLS CUI [2])
C0026265 (UMLS CUI [3])
Mitral valve prosthesis
Item
mitral valve prosthesis.
boolean
C0182494 (UMLS CUI [1])
Medical contraindication Vitamin K Antagonist
Item
contra indication to vitamin k antagonist
boolean
C1301624 (UMLS CUI [1,1])
C2267235 (UMLS CUI [1,2])
Resolution Lacking Intracardiac thrombus
Item
unresolved intra-cardiac thrombus
boolean
C1514893 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0876998 (UMLS CUI [1,3])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])

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