ID

44465

Description

Promote Q Cardiac Resynchronization Therapy Defibrillator (CRT-D) and Quartet Left Ventricular Heart Lead Study; ODM derived from: https://clinicaltrials.gov/show/NCT00990665

Link

https://clinicaltrials.gov/show/NCT00990665

Keywords

Versions (2)
  1. 4/4/18 4/4/18 -
  2. 9/27/21 9/27/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 27, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00990665

English

Eligibility Heart Failure NCT00990665

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
approved indication per acc/aha/hrs guidelines for implantation of a crt-d system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
Description

Indication Implantation of CRT-D | Therapeutic procedure Heart failure | Therapeutic procedure Ventricular Tachycardia Life Threatening

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1135480
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0018801
UMLS CUI [3,1]
C0087111
UMLS CUI [3,2]
C0042514
UMLS CUI [3,3]
C2826244
receiving a new implant or undergoing an upgrade from an existing icd or pacemaker implant with no prior lv lead placement.
Description

Implantable defibrillator insertion | Implantation of cardiac pacemaker | Upgrade Implantable defibrillator | Upgrade Artificial cardiac pacemaker | Implantation Lead Left ventricle Absent

Data type

boolean

Alias
UMLS CUI [1]
C0877213
UMLS CUI [2]
C0189842
UMLS CUI [3,1]
C3272274
UMLS CUI [3,2]
C0162589
UMLS CUI [4,1]
C3272274
UMLS CUI [4,2]
C0030163
UMLS CUI [5,1]
C0021107
UMLS CUI [5,2]
C0181586
UMLS CUI [5,3]
C0225897
UMLS CUI [5,4]
C0332197
ability to provide informed consent for study participation and is 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 had a recent cva or tia within three months of enrollment
Description

Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
have a contraindication for an emergency thoracotomy
Description

Medical contraindication Emergency Thoracotomy

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013956
UMLS CUI [1,3]
C0039991
have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
Description

Hypersensitivity Dexamethasone sodium phosphate Dose | Heparin allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0113286
UMLS CUI [1,3]
C0178602
UMLS CUI [2]
C0571776
have a classification of status 1 for cardiac transplantation or consideration for transplantation over the next 3 months
Description

Heart Transplantation Classification Status | Consideration Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C0008902
UMLS CUI [1,3]
C0449438
UMLS CUI [2,1]
C0518609
UMLS CUI [2,2]
C0018823
have undergone a cardiac transplantation within 40 days of enrollment
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
have had a recent myocardial infarction, unstable angina or cardiac revascularization (ptca, stent or 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
are currently participating in a clinical investigation that includes an active treatment arm
Description

Study Subject Participation Status | Clinical Trial Including Treatment Arm

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0332257
UMLS CUI [2,3]
C1522541
are pregnant or planning to become pregnant during the duration of the study
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 due to any condition
Description

Life Expectancy

Data type

boolean

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

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
are unable to comply with the follow up schedule
Description

Follow-up Compliance behavior Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1321605
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Heart Failure NCT00990665

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Implantation of CRT-D | Therapeutic procedure Heart failure | Therapeutic procedure Ventricular Tachycardia Life Threatening
Item
approved indication per acc/aha/hrs guidelines for implantation of a crt-d system for treatment of heart failure or lifethreatening ventricular tachyarrhythmia(s)
boolean
C3146298 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
C0087111 (UMLS CUI [3,1])
C0042514 (UMLS CUI [3,2])
C2826244 (UMLS CUI [3,3])
Implantable defibrillator insertion | Implantation of cardiac pacemaker | Upgrade Implantable defibrillator | Upgrade Artificial cardiac pacemaker | Implantation Lead Left ventricle Absent
Item
receiving a new implant or undergoing an upgrade from an existing icd or pacemaker implant with no prior lv lead placement.
boolean
C0877213 (UMLS CUI [1])
C0189842 (UMLS CUI [2])
C3272274 (UMLS CUI [3,1])
C0162589 (UMLS CUI [3,2])
C3272274 (UMLS CUI [4,1])
C0030163 (UMLS CUI [4,2])
C0021107 (UMLS CUI [5,1])
C0181586 (UMLS CUI [5,2])
C0225897 (UMLS CUI [5,3])
C0332197 (UMLS CUI [5,4])
Informed Consent | Protocol Compliance
Item
ability to provide informed consent for study participation and is 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)
Cerebrovascular accident | Transient Ischemic Attack
Item
have had a recent cva or tia within three months of enrollment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Medical contraindication Emergency Thoracotomy
Item
have a contraindication for an emergency thoracotomy
boolean
C1301624 (UMLS CUI [1,1])
C0013956 (UMLS CUI [1,2])
C0039991 (UMLS CUI [1,3])
Hypersensitivity Dexamethasone sodium phosphate Dose | Heparin allergy
Item
have a hypersensitivity to a single 1.0mg dose of dexamethasone sodium phosphate or short term contact with heparin
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
C0571776 (UMLS CUI [2])
Heart Transplantation Classification Status | 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 [1,1])
C0008902 (UMLS CUI [1,2])
C0449438 (UMLS CUI [1,3])
C0518609 (UMLS CUI [2,1])
C0018823 (UMLS CUI [2,2])
Heart Transplantation
Item
have undergone a cardiac transplantation within 40 days of enrollment
boolean
C0018823 (UMLS CUI [1])
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 (ptca, stent or 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])
Study Subject Participation Status | Clinical Trial Including Treatment Arm
Item
are currently participating in a clinical investigation that includes an active treatment arm
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0332257 (UMLS CUI [2,2])
C1522541 (UMLS CUI [2,3])
Pregnancy | Pregnancy, Planned
Item
are pregnant or planning to become pregnant during the duration of the study
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of less than 6 months due to any condition
boolean
C0023671 (UMLS CUI [1])
Age
Item
are less than 18 years of age
boolean
C0001779 (UMLS CUI [1])
Follow-up Compliance behavior Unable
Item
are unable to comply with the follow up schedule
boolean
C3274571 (UMLS CUI [1,1])
C1321605 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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