ID

17416

Beskrivning

B-Left HF: Biventricular Versus Left Univentricular Pacing With Implantable Cardiac Defibrillator (ICD) Back-Up in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00187213

Länk

https://clinicaltrials.gov/show/NCT00187213

Nyckelord

Versioner (1)
  1. 2016-09-12 2016-09-12 -
Uppladdad den

12 september 2016

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00187213

Engelsk

Eligibility Heart Failure NCT00187213

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
have an approved indication for implantation of an icd for treatment of a life-threatening ventricular tachyarrhythmia(s)
Beskrivning

Indication ICD Implantation | Tachycardia, Ventricular Life Threatening

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0162589
UMLS CUI [1,3]
C0021107
UMLS CUI [2,1]
C0042514
UMLS CUI [2,2]
C2826244
have advanced heart failure with a new york heart association (nyha) classification of iii or iv, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
Beskrivning

Heart failure Advanced | New York Heart Association Classification | Pharmacotherapy Optimal Stable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205179
UMLS CUI [2]
C1275491
UMLS CUI [3,1]
C0013216
UMLS CUI [3,2]
C2698651
UMLS CUI [3,3]
C0205360
have a ventricular conduction delay manifested as a qrs width >= 130 ms
Beskrivning

Ventricular conduction Delay | QRS complex

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0428933
UMLS CUI [1,2]
C0205421
UMLS CUI [2]
C0429098
have a left ventricular end diastolic diameter (lvedd) >= 55 mm
Beskrivning

Diastolic left ventricular diameter end diastolic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0919652
UMLS CUI [1,2]
C0442709
have a left ventricular ejection fraction (lvef) <= 35%
Beskrivning

Left ventricular ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0428772
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
have a crt device already implanted
Beskrivning

Cardiac Resynchronization Therapy Device Implanted

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2936377
UMLS CUI [1,2]
C0021102
have a standard indication for bradycardia pacing
Beskrivning

Indication Bradycardia pacing

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C0428977
UMLS CUI [1,3]
C0199640
have a history of chronic atrial fibrillation [af] (continuous af lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for af in the past month)
Beskrivning

Chronic atrial fibrillation | Atrial Fibrillation disease length | ATRIAL FIBRILLATION CARDIOVERSION

Datatyp

boolean

Alias
UMLS CUI [1]
C0694539
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0872146
UMLS CUI [3]
C0741278
have the ability to walk > 450 meters during the 6-minute walk test
Beskrivning

Able to walk Walking distance During 6-minute walk test

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2712089
UMLS CUI [1,2]
C0429886
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0430515
have uncorrected primary valvular disease
Beskrivning

Primary Valvular Disorder uncorrected

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274794
UMLS CUI [1,2]
C4072785
have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [ptca] or coronary artery bypass graft [cabg]) within 1 month of enrollment
Beskrivning

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

Datatyp

boolean

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

Cerebrovascular accident | Transient Ischemic Attack

Datatyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007787
have a life expectancy of less than one year
Beskrivning

Life Expectancy

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
are unable to comply with the follow-up schedule and tests
Beskrivning

Follow-up Adherence Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C3274571
UMLS CUI [1,2]
C1510802
UMLS CUI [1,3]
C1299582
are minors (age below 18 years)
Beskrivning

Minor | Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0026193
UMLS CUI [2]
C0001779
are pregnant or are planning for pregnancy in the next 6 months
Beskrivning

Pregnancy | Pregnancy, Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0032992
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Similar models

Eligibility Heart Failure NCT00187213

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Indication ICD Implantation | Tachycardia, Ventricular Life Threatening
Item
have an approved indication for implantation of an icd for treatment of a life-threatening ventricular tachyarrhythmia(s)
boolean
C3146298 (UMLS CUI [1,1])
C0162589 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
C0042514 (UMLS CUI [2,1])
C2826244 (UMLS CUI [2,2])
Heart failure Advanced | New York Heart Association Classification | Pharmacotherapy Optimal Stable
Item
have advanced heart failure with a new york heart association (nyha) classification of iii or iv, despite receiving a minimum of 30 days of stable optimal pharmacological therapy
boolean
C0018801 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C1275491 (UMLS CUI [2])
C0013216 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
C0205360 (UMLS CUI [3,3])
Ventricular conduction Delay | QRS complex
Item
have a ventricular conduction delay manifested as a qrs width >= 130 ms
boolean
C0428933 (UMLS CUI [1,1])
C0205421 (UMLS CUI [1,2])
C0429098 (UMLS CUI [2])
Diastolic left ventricular diameter end diastolic
Item
have a left ventricular end diastolic diameter (lvedd) >= 55 mm
boolean
C0919652 (UMLS CUI [1,1])
C0442709 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
have a left ventricular ejection fraction (lvef) <= 35%
boolean
C0428772 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Cardiac Resynchronization Therapy Device Implanted
Item
have a crt device already implanted
boolean
C2936377 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Indication Bradycardia pacing
Item
have a standard indication for bradycardia pacing
boolean
C3146298 (UMLS CUI [1,1])
C0428977 (UMLS CUI [1,2])
C0199640 (UMLS CUI [1,3])
Chronic atrial fibrillation | Atrial Fibrillation disease length | ATRIAL FIBRILLATION CARDIOVERSION
Item
have a history of chronic atrial fibrillation [af] (continuous af lasting > 1 month) within 1 year prior to enrollment or have undergone cardioversion for af in the past month)
boolean
C0694539 (UMLS CUI [1])
C0004238 (UMLS CUI [2,1])
C0872146 (UMLS CUI [2,2])
C0741278 (UMLS CUI [3])
Able to walk Walking distance During 6-minute walk test
Item
have the ability to walk > 450 meters during the 6-minute walk test
boolean
C2712089 (UMLS CUI [1,1])
C0429886 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0430515 (UMLS CUI [1,4])
Primary Valvular Disorder uncorrected
Item
have uncorrected primary valvular disease
boolean
C3274794 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Myocardial Revascularization | Percutaneous Transluminal Coronary Angioplasty | Coronary Artery Bypass Surgery
Item
have had a recent myocardial infarction, unstable angina or cardiac revascularization (percutaneous transluminal coronary angioplasty [ptca] or coronary artery bypass graft [cabg]) within 1 month of enrollment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C0027056 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
C0010055 (UMLS CUI [5])
Cerebrovascular accident | Transient Ischemic Attack
Item
have had cerebrovascular accident (cva) or transient ischemic attack (tia) within 3 months of enrollment
boolean
C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of less than one year
boolean
C0023671 (UMLS CUI [1])
Follow-up Adherence Unable
Item
are unable to comply with the follow-up schedule and tests
boolean
C3274571 (UMLS CUI [1,1])
C1510802 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Minor | Age
Item
are minors (age below 18 years)
boolean
C0026193 (UMLS CUI [1])
C0001779 (UMLS CUI [2])
Pregnancy | Pregnancy, Planned
Item
are pregnant or are planning for pregnancy in the next 6 months
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
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