ID

39515

Description

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

Keywords

  1. 1/21/20 1/21/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 21, 2020

DOI

To request one please log in.

License

Creative Commons BY 4.0

Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Heart Failure NCT02195843

Eligibility Heart Failure NCT02195843

Inclusion Criteria
Description

Inclusion Criteria

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

Age

Data type

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
Description

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

Data type

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.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

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

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

Data type

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.
Description

Ventricular Lead Epicardial

Data type

boolean

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

Activity Atrial Limited beats per minute

Data type

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.
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

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

Life Expectancy

Data type

boolean

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

Pregnancy

Data type

boolean

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

Dependence Inotropic agent Intravenous

Data type

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)
Data type
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])

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial