ID

29458

Description

Safety and Efficacy of Automatic Testing Feature in New ICDs and CRT-Ds; ODM derived from: https://clinicaltrials.gov/show/NCT00746356

Link

https://clinicaltrials.gov/show/NCT00746356

Keywords

Versions (1)
  1. 3/27/18 3/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00746356

English

Eligibility Heart Failure NCT00746356

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
have an approved indication, as outlined by american heart association/heart rhythm society (aha/hrs) guidelines, for implantation of an icd or crt-d for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of their icd or crt-d system to replace the pulse generator.
Description

Indication Implantation ICD | Indication Implantation of CRT-D | Therapeutic procedure Ventricular Tachycardia Life Threatening | Therapeutic procedure Heart failure Life Threatening | Revision ICD | Revision CRT-D System | Replacement Pulse Generator

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0021107
UMLS CUI [1,3]
C0162589
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0042514
UMLS CUI [3,3]
C2826244
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0018801
UMLS CUI [4,3]
C2826244
UMLS CUI [5,1]
C1527075
UMLS CUI [5,2]
C0162589
UMLS CUI [6,1]
C1527075
UMLS CUI [6,2]
C1736558
UMLS CUI [7,1]
C0559956
UMLS CUI [7,2]
C1140627
have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
Description

Informed Consent | Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C0525058
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a classification of status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.
Description

Heart Transplantation | Consideration Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0018823
have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (ptca), stent or coronary artery bypass graft(cabg)) within 40 days of enrollment.
Description

Myocardial Infarction | Angina, Unstable | Myocardial Revascularization | Percutaneous Transluminal Coronary Angioplasty | Stent | Coronary Artery Bypass Surgery

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C0002965
UMLS CUI [3]
C0027056
UMLS CUI [4]
C2936173
UMLS CUI [5]
C0038257
UMLS CUI [6]
C0010055
have had a recent cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months of enrollment.
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
are allergic to dexamethasone sodium phosphate (dsp).
Description

Hypersensitivity Dexamethasone sodium phosphate

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
be currently participating in a clinical investigation that includes an active treatment arm.
Description

Study Subject Participation Status | Treatment Arm Included

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C1522541
UMLS CUI [2,2]
C0332257
be pregnant or are planning for pregnancy within 6 months following enrollment.
Description

Pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
have a life expectancy of less than 6 months.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
be less than 18 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
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Similar models

Eligibility Heart Failure NCT00746356

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation ICD | Indication Implantation of CRT-D | Therapeutic procedure Ventricular Tachycardia Life Threatening | Therapeutic procedure Heart failure Life Threatening | Revision ICD | Revision CRT-D System | Replacement Pulse Generator
Item
have an approved indication, as outlined by american heart association/heart rhythm society (aha/hrs) guidelines, for implantation of an icd or crt-d for the treatment of life-threatening ventricular tachyarrhythmia(s) or heart failure, or undergo revision of their icd or crt-d system to replace the pulse generator.
boolean
C3146298 (UMLS CUI [1,1])
C0021107 (UMLS CUI [1,2])
C0162589 (UMLS CUI [1,3])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0042514 (UMLS CUI [3,2])
C2826244 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0018801 (UMLS CUI [4,2])
C2826244 (UMLS CUI [4,3])
C1527075 (UMLS CUI [5,1])
C0162589 (UMLS CUI [5,2])
C1527075 (UMLS CUI [6,1])
C1736558 (UMLS CUI [6,2])
C0559956 (UMLS CUI [7,1])
C1140627 (UMLS CUI [7,2])
Informed Consent | Protocol Compliance
Item
have the ability to provide informed consent for study participation and be willing and able to comply with the prescribed follow-up tests and schedule of evaluations.
boolean
C0021430 (UMLS CUI [1])
C0525058 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Heart Transplantation | Consideration Heart Transplantation
Item
have a classification of status 1 for cardiac transplantation or consideration for transplantation over the next 3 months.
boolean
C0018823 (UMLS CUI [1])
C0518609 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
Myocardial Infarction | Angina, Unstable | Myocardial Revascularization | Percutaneous Transluminal Coronary Angioplasty | Stent | Coronary Artery Bypass Surgery
Item
have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty (ptca), stent or coronary artery bypass graft(cabg)) within 40 days of enrollment.
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027056 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0038257 (UMLS CUI [5])
C0010055 (UMLS CUI [6])
Cerebrovascular accident | Transient Ischemic Attack
Item
have had a recent cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months of enrollment.
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Hypersensitivity Dexamethasone sodium phosphate
Item
are allergic to dexamethasone sodium phosphate (dsp).
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
Study Subject Participation Status | Treatment Arm Included
Item
be currently participating in a clinical investigation that includes an active treatment arm.
boolean
C2348568 (UMLS CUI [1])
C1522541 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
Pregnancy | Pregnancy, Planned
Item
be pregnant or are planning for pregnancy within 6 months following enrollment.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of less than 6 months.
boolean
C0023671 (UMLS CUI [1])
Age
Item
be less than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
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