ID

44426

Description

OVATIO CRT and SITUS OTW LV Lead Post Approval Study; ODM derived from: https://clinicaltrials.gov/show/NCT00795873

Link

https://clinicaltrials.gov/show/NCT00795873

Keywords

Versions (2)
  1. 3/28/18 3/28/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00795873

English

Eligibility Heart Failure NCT00795873

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
nyha class iii/iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
stable medical regimen
Description

Therapeutic procedure Stable

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
qrs greater than or equal to 130 ms
Description

QRS complex duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
lvef less than or equal to 35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
vt of transient or reversible causes
Description

Ventricular Tachycardia Cause Transient | Ventricular Tachycardia Cause Reversible

Data type

boolean

Alias
UMLS CUI [1,1]
C0042514
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0205374
UMLS CUI [2,1]
C0042514
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C0205343
incessant vt
Description

Incessant ventricular tachycardia

Data type

boolean

Alias
UMLS CUI [1]
C2363809
currently implanted with a lead positioned through the coronary sinus (unless it is the situs otw lv lead)
Description

Implant Lead Coronary sinus

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C0456944
cardiac revascularization or angioplasty within the last month
Description

Myocardial Revascularization | Angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0027056
UMLS CUI [2]
C0162577
heart failure due to correctable valve disease
Description

Heart failure Due to Valvular disease | Valvular disease Correction Possible

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C3258293
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C1947976
UMLS CUI [2,3]
C0332149
chronic, medially refractory at
Description

Atrial tachycardia chronic refractory

Data type

boolean

Alias
UMLS CUI [1,1]
C0546959
UMLS CUI [1,2]
C0205191
UMLS CUI [1,3]
C0205269
enrolled in another clinical study that may confound the results of this study
Description

Study Subject Participation Status Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
life expectancy less than 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
inability to understand the purpose of the study or refusal to cooperate
Description

Study Protocol Comprehension Unable | Patient cooperation Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C2348563
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
UMLS CUI [2,1]
C1321605
UMLS CUI [2,2]
C1705116
inability or refusal to provide informed consent
Description

Informed Consent Unable | Informed Consent Refused

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C1705116
unavailable for scheduled follow-up with the implanting practice
Description

Patient unavailable Follow-up | Patient unavailable Implantation procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301818
UMLS CUI [1,2]
C3274571
UMLS CUI [2,1]
C1301818
UMLS CUI [2,2]
C0021107
sensitivity to 1 mg dexamethasone sodium phosphate
Description

Hypersensitivity Dexamethasone sodium phosphate Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
UMLS CUI [1,3]
C0178602
less than 18 years of age
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
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Similar models

Eligibility Heart Failure NCT00795873

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
New York Heart Association Classification
Item
nyha class iii/iv
boolean
C1275491 (UMLS CUI [1])
Therapeutic procedure Stable
Item
stable medical regimen
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
QRS complex duration
Item
qrs greater than or equal to 130 ms
boolean
C0429025 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef less than or equal to 35%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Ventricular Tachycardia Cause Transient | Ventricular Tachycardia Cause Reversible
Item
vt of transient or reversible causes
boolean
C0042514 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0205374 (UMLS CUI [1,3])
C0042514 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C0205343 (UMLS CUI [2,3])
Incessant ventricular tachycardia
Item
incessant vt
boolean
C2363809 (UMLS CUI [1])
Implant Lead Coronary sinus
Item
currently implanted with a lead positioned through the coronary sinus (unless it is the situs otw lv lead)
boolean
C0021102 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C0456944 (UMLS CUI [1,3])
Myocardial Revascularization | Angioplasty
Item
cardiac revascularization or angioplasty within the last month
boolean
C0027056 (UMLS CUI [1])
C0162577 (UMLS CUI [2])
Heart failure Due to Valvular disease | Valvular disease Correction Possible
Item
heart failure due to correctable valve disease
boolean
C0018801 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C3258293 (UMLS CUI [1,3])
C3258293 (UMLS CUI [2,1])
C1947976 (UMLS CUI [2,2])
C0332149 (UMLS CUI [2,3])
Atrial tachycardia chronic refractory
Item
chronic, medially refractory at
boolean
C0546959 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0205269 (UMLS CUI [1,3])
Study Subject Participation Status Interferes with Research results
Item
enrolled in another clinical study that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy
Item
life expectancy less than 6 months
boolean
C0023671 (UMLS CUI [1])
Study Protocol Comprehension Unable | Patient cooperation Refused
Item
inability to understand the purpose of the study or refusal to cooperate
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Informed Consent Unable | Informed Consent Refused
Item
inability or refusal to provide informed consent
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Patient unavailable Follow-up | Patient unavailable Implantation procedure
Item
unavailable for scheduled follow-up with the implanting practice
boolean
C1301818 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])
C1301818 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
Hypersensitivity Dexamethasone sodium phosphate Dose
Item
sensitivity to 1 mg dexamethasone sodium phosphate
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Age
Item
less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
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