ID

20248

Description

COSMO Post Approval Registry: Corox OTW Steroid LV Lead Monitoring; ODM derived from: https://clinicaltrials.gov/show/NCT00396136

Link

https://clinicaltrials.gov/show/NCT00396136

Keywords

  1. 2/16/17 2/16/17 -
Uploaded on

February 16, 2017

DOI

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License

Creative Commons BY 4.0

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Eligibility Congestive Heart Failure NCT00396136

Eligibility Congestive Heart Failure NCT00396136

Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
successfully implanted biotronik crt-d system, including the corox otw steroid lv lead, from 1-30 days prior to enrollment
Description

Implantation of CRT-D

Data type

boolean

Alias
UMLS CUI [1]
C1135480
able to understand the nature of the registry and give informed consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
available for follow-up visits on a regular basis at the investigational site
Description

Follow-up visit Patient Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0589121
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0470187
age greater than or equal to 18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
enrolled in another cardiovascular or pharmacological clinical investigation
Description

Study Subject Participation Status | Clinical Trial Cardiovascular | Clinical Trial pharmacological

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C3887460
UMLS CUI [3,1]
C0008976
UMLS CUI [3,2]
C0205464
planned cardiac surgical procedures or interventional measures within the next 6 months
Description

Cardiac Surgery procedures Planned | Interventional procedure Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0184661
UMLS CUI [2,2]
C1301732
expected to receive a heart transplant within 6 months
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
life expectancy less than 6 months
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
presence of another life-threatening, underlying illness separate from their cardiac disorder
Description

Comorbidity Life Threatening | Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
UMLS CUI [2]
C0018799
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961

Similar models

Eligibility Congestive Heart Failure NCT00396136

Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Implantation of CRT-D
Item
successfully implanted biotronik crt-d system, including the corox otw steroid lv lead, from 1-30 days prior to enrollment
boolean
C1135480 (UMLS CUI [1])
Informed Consent
Item
able to understand the nature of the registry and give informed consent
boolean
C0021430 (UMLS CUI [1])
Follow-up visit Patient Available
Item
available for follow-up visits on a regular basis at the investigational site
boolean
C0589121 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0470187 (UMLS CUI [1,3])
Age
Item
age greater than or equal to 18 years
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Study Subject Participation Status | Clinical Trial Cardiovascular | Clinical Trial pharmacological
Item
enrolled in another cardiovascular or pharmacological clinical investigation
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C3887460 (UMLS CUI [2,2])
C0008976 (UMLS CUI [3,1])
C0205464 (UMLS CUI [3,2])
Cardiac Surgery procedures Planned | Interventional procedure Planned
Item
planned cardiac surgical procedures or interventional measures within the next 6 months
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0184661 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Heart Transplantation Expected
Item
expected to receive a heart transplant within 6 months
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy less than 6 months
boolean
C0023671 (UMLS CUI [1])
Comorbidity Life Threatening | Heart Disease
Item
presence of another life-threatening, underlying illness separate from their cardiac disorder
boolean
C0009488 (UMLS CUI [1,1])
C2826244 (UMLS CUI [1,2])
C0018799 (UMLS CUI [2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])

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