ID

44562

Description

Effect of Targeting Left Ventricular Lead Position on the Rate of Response to Cardiac Resynchronization Therapy.; ODM derived from: https://clinicaltrials.gov/show/NCT00399594

Link

https://clinicaltrials.gov/show/NCT00399594

Keywords

Versions (2)
  1. 5/28/20 5/28/20 -
  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, Congestive NCT00399594

English

Eligibility Heart Failure, Congestive NCT00399594

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
lv ef ≤ 0.40 measured within 3 months of enrollment,
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
sas class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
Description

Other Coding | Heart failure Moderate | Heart failure Severe

Data type

boolean

Alias
UMLS CUI [1]
C3846158
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0018801
UMLS CUI [3,2]
C0205082
confirmed dyssynchrony on screening echo (1.1.9), &
Description

Ventricular dyssynchrony Confirmed by Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C3160931
UMLS CUI [1,2]
C0521093
UMLS CUI [1,3]
C0013516
on stable doses of ace inhibitor or angiotensin ii blocker & a beta-blocker for ≥ 2 months unless medically contra-indicated.
Description

Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable | Exception Contraindicated

Data type

boolean

Alias
UMLS CUI [1,1]
C0003015
UMLS CUI [1,2]
C0178602
UMLS CUI [1,3]
C0205360
UMLS CUI [2,1]
C0521942
UMLS CUI [2,2]
C0178602
UMLS CUI [2,3]
C0205360
UMLS CUI [3,1]
C0304516
UMLS CUI [3,2]
C0178602
UMLS CUI [3,3]
C0205360
UMLS CUI [4,1]
C1705847
UMLS CUI [4,2]
C1444657
controlled heart rate if in permanent af (resting <70 & maximal <120).
Description

Heart rate Controlled | Permanent atrial fibrillation | RESTING HEART RATE | Heart rate Maximal

Data type

boolean

Alias
UMLS CUI [1,1]
C0018810
UMLS CUI [1,2]
C2587213
UMLS CUI [2]
C2586056
UMLS CUI [3]
C1821417
UMLS CUI [4,1]
C0018810
UMLS CUI [4,2]
C0205289
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
unable or unwilling to provide informed consent,
Description

Informed Consent Unable | Informed Consent Unwilling

Data type

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0558080
medical condition other than heart failure likely to cause death < 1 year,
Description

Other medical condition Causing Death | Exception Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0011065
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018801
cardiac transplant planned within 6 months,
Description

Heart Transplantation Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1301732
known contra-indication to transvenous crt device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
Description

Medical contraindication Implantation of CRT-D Transvenous | Sepsis | Tricuspid valve prosthesis | Vascular occlusion

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C1135480
UMLS CUI [1,3]
C0522521
UMLS CUI [2]
C0243026
UMLS CUI [3]
C1322659
UMLS CUI [4]
C1096458
clinically significant myocardial infarction within last 2 months, or
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month
Description

Coronary Artery Bypass Surgery | Coronary angioplasty

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2]
C0190211
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Similar models

Eligibility Heart Failure, Congestive NCT00399594

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Left ventricular ejection fraction
Item
lv ef ≤ 0.40 measured within 3 months of enrollment,
boolean
C0428772 (UMLS CUI [1])
Other Coding | Heart failure Moderate | Heart failure Severe
Item
sas class 3 or 4 symptoms indicative of moderate to severe functional capacity limitation due to heart failure within 1 month of enrollment.
boolean
C3846158 (UMLS CUI [1])
C0018801 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0018801 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Ventricular dyssynchrony Confirmed by Echocardiography
Item
confirmed dyssynchrony on screening echo (1.1.9), &
boolean
C3160931 (UMLS CUI [1,1])
C0521093 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Angiotensin-Converting Enzyme Inhibitors Dose Stable | Angiotensin II receptor antagonist Dose Stable | Adrenergic beta-1 Receptor Antagonists Dose Stable | Exception Contraindicated
Item
on stable doses of ace inhibitor or angiotensin ii blocker & a beta-blocker for ≥ 2 months unless medically contra-indicated.
boolean
C0003015 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
C0521942 (UMLS CUI [2,1])
C0178602 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
C0304516 (UMLS CUI [3,1])
C0178602 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
C1705847 (UMLS CUI [4,1])
C1444657 (UMLS CUI [4,2])
Heart rate Controlled | Permanent atrial fibrillation | RESTING HEART RATE | Heart rate Maximal
Item
controlled heart rate if in permanent af (resting <70 & maximal <120).
boolean
C0018810 (UMLS CUI [1,1])
C2587213 (UMLS CUI [1,2])
C2586056 (UMLS CUI [2])
C1821417 (UMLS CUI [3])
C0018810 (UMLS CUI [4,1])
C0205289 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
Informed Consent Unable | Informed Consent Unwilling
Item
unable or unwilling to provide informed consent,
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])
Other medical condition Causing Death | Exception Heart failure
Item
medical condition other than heart failure likely to cause death < 1 year,
boolean
C3843040 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0011065 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018801 (UMLS CUI [2,2])
Heart Transplantation Planned
Item
cardiac transplant planned within 6 months,
boolean
C0018823 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Medical contraindication Implantation of CRT-D Transvenous | Sepsis | Tricuspid valve prosthesis | Vascular occlusion
Item
known contra-indication to transvenous crt device implant (e.g., active sepsis, artificial tricuspid valve, known vascular occlusion that will prevent delivery of leads transvenously),
boolean
C1301624 (UMLS CUI [1,1])
C1135480 (UMLS CUI [1,2])
C0522521 (UMLS CUI [1,3])
C0243026 (UMLS CUI [2])
C1322659 (UMLS CUI [3])
C1096458 (UMLS CUI [4])
Myocardial Infarction
Item
clinically significant myocardial infarction within last 2 months, or
boolean
C0027051 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Coronary angioplasty
Item
coronary bypass graft surgery ≤ 2 months or coronary angioplasty ≤ 1 month
boolean
C0010055 (UMLS CUI [1])
C0190211 (UMLS CUI [2])
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