ID

39515

Beschrijving

Quadripolar Leads for the Management of Heart Failure Patients in the Middle East; ODM derived from: https://clinicaltrials.gov/show/NCT02195843

Link

https://clinicaltrials.gov/show/NCT02195843

Trefwoorden

  1. 21-01-20 21-01-20 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

21 januari 2020

DOI

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Licentie

Creative Commons BY 4.0

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Eligibility Heart Failure NCT02195843

Eligibility Heart Failure NCT02195843

Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
male or female patients ≥ 18 years of age
Beschrijving

Age

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
patient met standard crt-d device indications (left ventricular ejection fraction (lvef) ≤ 35%, qrs ≥ 120 ms, new york heart association (nyha) class ii, iii or ambulatory class iv heart failure (hf) symptoms with optimal recommended medical therapy) and will be implanted with an st jude medical crt-d
Beschrijving

Indication Implantation of CRT-D | Left ventricular ejection fraction | QRS duration | Heart failure Symptoms New York Heart Association Classification | Heart failure Symptoms Ambulatory New York Heart Association Classification | Therapy Optimal | Implantation of CRT-D Planned

Datatype

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1135480
UMLS CUI [2]
C0428772
UMLS CUI [3]
C0429025
UMLS CUI [4,1]
C0018801
UMLS CUI [4,2]
C1457887
UMLS CUI [4,3]
C1275491
UMLS CUI [5,1]
C0018801
UMLS CUI [5,2]
C1457887
UMLS CUI [5,3]
C1561561
UMLS CUI [5,4]
C1275491
UMLS CUI [6,1]
C0087111
UMLS CUI [6,2]
C2698651
UMLS CUI [7,1]
C1135480
UMLS CUI [7,2]
C1301732
patient is willing to provide written informed consent.
Beschrijving

Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with non left bundle branch block (rbbb, intraventricular delay (ivcd) block)
Beschrijving

Left Bundle-Branch Block Absent | Right bundle branch block | Intraventricular conduction delay

Datatype

boolean

Alias
UMLS CUI [1,1]
C0023211
UMLS CUI [1,2]
C0332197
UMLS CUI [2]
C0085615
UMLS CUI [3]
C0259758
patient has an epicardial ventricular lead system.
Beschrijving

Ventricular Lead Epicardial

Datatype

boolean

Alias
UMLS CUI [1,1]
C2825199
UMLS CUI [1,2]
C0442016
patient has limited intrinsic atrial activity (≤ 40 bpm).
Beschrijving

Activity Atrial Limited beats per minute

Datatype

boolean

Alias
UMLS CUI [1,1]
C0205177
UMLS CUI [1,2]
C0018792
UMLS CUI [1,3]
C0439801
UMLS CUI [1,4]
C0439385
patient has persistent or permanent atrial fibrillation.
Beschrijving

Persistent atrial fibrillation | Permanent atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
patient's life expectancy is less than 1 year
Beschrijving

Life Expectancy

Datatype

boolean

Alias
UMLS CUI [1]
C0023671
patient is pregnant.
Beschrijving

Pregnancy

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
patient is dependent on iv inotropic agents.
Beschrijving

Dependence Inotropic agent Intravenous

Datatype

boolean

Alias
UMLS CUI [1,1]
C0439857
UMLS CUI [1,2]
C0304509
UMLS CUI [1,3]
C1522726

Similar models

Eligibility Heart Failure NCT02195843

Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
male or female patients ≥ 18 years of age
boolean
C0001779 (UMLS CUI [1])
Indication Implantation of CRT-D | Left ventricular ejection fraction | QRS duration | Heart failure Symptoms New York Heart Association Classification | Heart failure Symptoms Ambulatory New York Heart Association Classification | Therapy Optimal | Implantation of CRT-D Planned
Item
patient met standard crt-d device indications (left ventricular ejection fraction (lvef) ≤ 35%, qrs ≥ 120 ms, new york heart association (nyha) class ii, iii or ambulatory class iv heart failure (hf) symptoms with optimal recommended medical therapy) and will be implanted with an st jude medical crt-d
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C1457887 (UMLS CUI [4,2])
C1275491 (UMLS CUI [4,3])
C0018801 (UMLS CUI [5,1])
C1457887 (UMLS CUI [5,2])
C1561561 (UMLS CUI [5,3])
C1275491 (UMLS CUI [5,4])
C0087111 (UMLS CUI [6,1])
C2698651 (UMLS CUI [6,2])
C1135480 (UMLS CUI [7,1])
C1301732 (UMLS CUI [7,2])
Informed Consent
Item
patient is willing to provide written informed consent.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Left Bundle-Branch Block Absent | Right bundle branch block | Intraventricular conduction delay
Item
patient with non left bundle branch block (rbbb, intraventricular delay (ivcd) block)
boolean
C0023211 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0085615 (UMLS CUI [2])
C0259758 (UMLS CUI [3])
Ventricular Lead Epicardial
Item
patient has an epicardial ventricular lead system.
boolean
C2825199 (UMLS CUI [1,1])
C0442016 (UMLS CUI [1,2])
Activity Atrial Limited beats per minute
Item
patient has limited intrinsic atrial activity (≤ 40 bpm).
boolean
C0205177 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
C0439385 (UMLS CUI [1,4])
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
patient has persistent or permanent atrial fibrillation.
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Life Expectancy
Item
patient's life expectancy is less than 1 year
boolean
C0023671 (UMLS CUI [1])
Pregnancy
Item
patient is pregnant.
boolean
C0032961 (UMLS CUI [1])
Dependence Inotropic agent Intravenous
Item
patient is dependent on iv inotropic agents.
boolean
C0439857 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
C1522726 (UMLS CUI [1,3])

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