ID

39388

Description

Model 4296 Left Ventricular (LV) Lead Study; ODM derived from: https://clinicaltrials.gov/show/NCT00927251

Link

https://clinicaltrials.gov/show/NCT00927251

Keywords

Versions (1)
  1. 1/6/20 1/6/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 6, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00927251

English

Eligibility Heart Failure NCT00927251

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
cardiac resynchronization therapy (crt)/cardiac resynchronization therapy-defibrillator (crt-d) indications according to the european society of cardiology/american college of cardiology/american heart association (esc/acc/aha) guidelines
Description

Indication Cardiac Resynchronization Therapy | Indication Implantation of CRT-D

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1167956
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C1135480
on optimal medical treatment according to investigator opinion
Description

Therapy Optimal

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
indicated for implantable cardioverter defibrillator (icd) if crt-d is implanted
Description

Indication Implantable defibrillator | Implantation of CRT-D

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0162589
UMLS CUI [2]
C1135480
patient consent
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
geographically stable
Description

Stable status Geographic

Data type

boolean

Alias
UMLS CUI [1,1]
C0205360
UMLS CUI [1,2]
C1517526
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
left ventricular (lv) lead implant attempt in last 30 days
Description

Implant Attempt Ventricular Lead Left

Data type

boolean

Alias
UMLS CUI [1,1]
C0021102
UMLS CUI [1,2]
C1516084
UMLS CUI [1,3]
C2825199
UMLS CUI [1,4]
C0443246
unstable angina or acute myocardial infarction (mi) in past 30 days
Description

Angina, Unstable | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0027051
coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) in past 90 days
Description

Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C1532338
contraindicated for transvenous pacing
Description

Medical contraindication Cardiac transvenous pacemaker

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0336574
heart transplant
Description

Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018823
contraindicated for less than 1 milligram (mg) dexamethasone acetate
Description

Medical contraindication Dexamethasone acetate Dose

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0057598
UMLS CUI [1,3]
C0178602
enrolled or intends to participate in concurrent drug and/or device study which would confound results
Description

Study Subject Participation Status | Investigational New Drug Interferes with Research results | Investigational Medical Device Interferes with Research results

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0013230
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C2346570
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683954
life expectancy shorter than duration of the study
Description

Life Expectancy Less Than Planned Trial Duration

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0439092
UMLS CUI [1,3]
C4288390
exclusion criteria required by local law
Description

Exclusion Criteria Law Local

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C0220866
UMLS CUI [1,3]
C0205276
unable to tolerate urgent thoracotomy
Description

Thoracotomy Receive Unable

Data type

boolean

Alias
UMLS CUI [1,1]
C0039991
UMLS CUI [1,2]
C1514756
UMLS CUI [1,3]
C1299582
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Similar models

Eligibility Heart Failure NCT00927251

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Indication Cardiac Resynchronization Therapy | Indication Implantation of CRT-D
Item
cardiac resynchronization therapy (crt)/cardiac resynchronization therapy-defibrillator (crt-d) indications according to the european society of cardiology/american college of cardiology/american heart association (esc/acc/aha) guidelines
boolean
C3146298 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
Therapy Optimal
Item
on optimal medical treatment according to investigator opinion
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
Indication Implantable defibrillator | Implantation of CRT-D
Item
indicated for implantable cardioverter defibrillator (icd) if crt-d is implanted
boolean
C3146298 (UMLS CUI [1,1])
C0162589 (UMLS CUI [1,2])
C1135480 (UMLS CUI [2])
Informed Consent
Item
patient consent
boolean
C0021430 (UMLS CUI [1])
Stable status Geographic
Item
geographically stable
boolean
C0205360 (UMLS CUI [1,1])
C1517526 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Implant Attempt Ventricular Lead Left
Item
left ventricular (lv) lead implant attempt in last 30 days
boolean
C0021102 (UMLS CUI [1,1])
C1516084 (UMLS CUI [1,2])
C2825199 (UMLS CUI [1,3])
C0443246 (UMLS CUI [1,4])
Angina, Unstable | Myocardial Infarction
Item
unstable angina or acute myocardial infarction (mi) in past 30 days
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
coronary artery bypass graft (cabg) or percutaneous transluminal coronary angioplasty (ptca) in past 90 days
boolean
C0010055 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
Medical contraindication Cardiac transvenous pacemaker
Item
contraindicated for transvenous pacing
boolean
C1301624 (UMLS CUI [1,1])
C0336574 (UMLS CUI [1,2])
Heart Transplantation
Item
heart transplant
boolean
C0018823 (UMLS CUI [1])
Medical contraindication Dexamethasone acetate Dose
Item
contraindicated for less than 1 milligram (mg) dexamethasone acetate
boolean
C1301624 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Study Subject Participation Status | Investigational New Drug Interferes with Research results | Investigational Medical Device Interferes with Research results
Item
enrolled or intends to participate in concurrent drug and/or device study which would confound results
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C2346570 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683954 (UMLS CUI [3,3])
Life Expectancy Less Than Planned Trial Duration
Item
life expectancy shorter than duration of the study
boolean
C0023671 (UMLS CUI [1,1])
C0439092 (UMLS CUI [1,2])
C4288390 (UMLS CUI [1,3])
Exclusion Criteria Law Local
Item
exclusion criteria required by local law
boolean
C0680251 (UMLS CUI [1,1])
C0220866 (UMLS CUI [1,2])
C0205276 (UMLS CUI [1,3])
Thoracotomy Receive Unable
Item
unable to tolerate urgent thoracotomy
boolean
C0039991 (UMLS CUI [1,1])
C1514756 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
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