ID

28383

Description

Post Approval Registry of Corox OTW, Endocardial, Left Ventricular Steroid Lead, Bipolar; ODM derived from: https://clinicaltrials.gov/show/NCT00810264

Link

https://clinicaltrials.gov/show/NCT00810264

Keywords

Versions (1)
  1. 1/9/18 1/9/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 9, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Congestive Heart Failure NCT00810264

English

Eligibility Congestive Heart Failure NCT00810264

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
successfully implanted biotronik crt system, including a corox bp lv lead, from 7-180 days prior to enrollment
Description

Cardiac Resynchronization Therapy Device Implantation Successful | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C1272703
UMLS CUI [2]
C3846158
able to understand the nature of the registry and give informed consent
Description

Comprehension Enrollment | Informed Consent

Data type

boolean

Alias
UMLS CUI [1,1]
C0162340
UMLS CUI [1,2]
C1516879
UMLS CUI [2]
C0021430
available for follow-up visits on a regular basis at the investigational site
Description

Patient Available Follow-up visit

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0470187
UMLS CUI [1,3]
C0589121
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 any ide clinical study
Description

Study Subject Participation Status | IDE Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C2826366
UMLS CUI [2,2]
C0008976
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 1 year
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
life expectancy less than 1 year
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 | Independent of Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C2826244
UMLS CUI [2,1]
C0332291
UMLS CUI [2,2]
C0018799
pregnancy
Description

Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
Description

Protocol Compliance Unable | Implant Date No Information Available | Device implant No Information Available | Age No Information Available | Gender No Information Available | Adverse event No Information Available

Data type

boolean

Alias
UMLS CUI [1,1]
C0525058
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021107
UMLS CUI [2,2]
C0011008
UMLS CUI [2,3]
C1546437
UMLS CUI [3,1]
C0948629
UMLS CUI [3,2]
C1546437
UMLS CUI [4,1]
C0001779
UMLS CUI [4,2]
C1546437
UMLS CUI [5,1]
C0079399
UMLS CUI [5,2]
C1546437
UMLS CUI [6,1]
C0877248
UMLS CUI [6,2]
C1546437
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Similar models

Eligibility Congestive Heart Failure NCT00810264

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Resynchronization Therapy Device Implantation Successful | Other Coding
Item
successfully implanted biotronik crt system, including a corox bp lv lead, from 7-180 days prior to enrollment
boolean
C2936377 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C1272703 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Comprehension Enrollment | Informed Consent
Item
able to understand the nature of the registry and give informed consent
boolean
C0162340 (UMLS CUI [1,1])
C1516879 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2])
Patient Available Follow-up visit
Item
available for follow-up visits on a regular basis at the investigational site
boolean
C0030705 (UMLS CUI [1,1])
C0470187 (UMLS CUI [1,2])
C0589121 (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 | IDE Clinical Trial
Item
enrolled in any ide clinical study
boolean
C2348568 (UMLS CUI [1])
C2826366 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
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 1 year
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Life Expectancy
Item
life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Comorbidity Life Threatening | Independent of 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])
C0332291 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Pregnancy
Item
pregnancy
boolean
C0032961 (UMLS CUI [1])
Protocol Compliance Unable | Implant Date No Information Available | Device implant No Information Available | Age No Information Available | Gender No Information Available | Adverse event No Information Available
Item
inability to provide date of implant, devices implanted, age, gender, and whether the patient experienced any protocol-defined adverse events since implant
boolean
C0525058 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021107 (UMLS CUI [2,1])
C0011008 (UMLS CUI [2,2])
C1546437 (UMLS CUI [2,3])
C0948629 (UMLS CUI [3,1])
C1546437 (UMLS CUI [3,2])
C0001779 (UMLS CUI [4,1])
C1546437 (UMLS CUI [4,2])
C0079399 (UMLS CUI [5,1])
C1546437 (UMLS CUI [5,2])
C0877248 (UMLS CUI [6,1])
C1546437 (UMLS CUI [6,2])
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