ID

39379

Description

Resynchronization/Defibrillation for Ambulatory Heart Failure Trial in Patients With Permanent Atrial Fibrillation; ODM derived from: https://clinicaltrials.gov/show/NCT01994252

Link

https://clinicaltrials.gov/show/NCT01994252

Keywords

Versions (1)
  1. 1/5/20 1/5/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 5, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Disease NCT01994252

English

Eligibility Heart Disease NCT01994252

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patients with nyha class ii or iii hf symptoms (assessment in the last 3 months)
Description

Symptoms Heart failure New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C1457887
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C1275491
permanent af
Description

Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2586056
optimal medical therapy for hf of at least 3 months (according to 2009 accf/aha and esc 2012 recommendations,)
Description

Therapy Optimal Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
lvef ≤ 35% (assessment in the last 6 months)
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
candidacy for an icd for primary or secondary prevention of sudden cardiac death
Description

Patient Appropriate ICD | Primary Prevention Sudden Cardiac Death | Secondary Prevention Sudden Cardiac Death

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548787
UMLS CUI [1,3]
C0162589
UMLS CUI [2,1]
C0033144
UMLS CUI [2,2]
C0085298
UMLS CUI [3,1]
C0679699
UMLS CUI [3,2]
C0085298
qrs durations ≥ 130 ms when the qrs morphology is lbbb, or qrs durations ≥ 150 ms when the qrs morphology is non-lbbb or paced qrs
Description

QRS duration | Left Bundle-Branch Block | Left Bundle-Branch Block Absent | QRS duration Paced

Data type

boolean

Alias
UMLS CUI [1]
C0429025
UMLS CUI [2]
C0023211
UMLS CUI [3,1]
C0023211
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0429025
UMLS CUI [4,2]
C2981711
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
in-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
Description

inpatient | Heart Disease | Illness | intensive care Required

Data type

boolean

Alias
UMLS CUI [1]
C0021562
UMLS CUI [2]
C0018799
UMLS CUI [3]
C0221423
UMLS CUI [4,1]
C0085559
UMLS CUI [4,2]
C1514873
intra-venous inotropic agent in the last 4 days
Description

Inotropic agent Intravenous

Data type

boolean

Alias
UMLS CUI [1,1]
C0304509
UMLS CUI [1,2]
C1522726
patients with a life expectancy of less than one year from non-cardiac cause.
Description

Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0023671
expected to undergo cardiac transplantation within one year (status i)
Description

Heart Transplantation Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018823
UMLS CUI [1,2]
C1517001
acute coronary syndrome (including mi) < 4 weeks
Description

Acute Coronary Syndrome | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
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
uncorrected or uncorrectable primary valvular disease
Description

Valvular disease uncorrected

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C4072785
restrictive, hypertrophic or reversible form of cardiomyopathy
Description

Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Cardiomyopathy Reversible

Data type

boolean

Alias
UMLS CUI [1]
C0007196
UMLS CUI [2]
C0007194
UMLS CUI [3,1]
C0878544
UMLS CUI [3,2]
C0205343
severe primary pulmonary disease such as cor pulmonale
Description

Lung disease Severe | Cor pulmonale

Data type

boolean

Alias
UMLS CUI [1,1]
C0024115
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0034072
tricuspid prosthetic valve
Description

Tricuspid valve Prosthetic

Data type

boolean

Alias
UMLS CUI [1,1]
C0040960
UMLS CUI [1,2]
C0175649
patients included in other clinical trial that will affect the objectives of this study
Description

Study Subject Participation Status | Clinical Trial Affecting Research data

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2,1]
C0008976
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0681873
coronary revascularization (cabg or pci) < 3 months
Description

Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0877341
UMLS CUI [2]
C0010055
UMLS CUI [3]
C1532338
patients with an existing icd or crt pacemaker
Description

ICD | CRT pacemaker

Data type

boolean

Alias
UMLS CUI [1]
C0162589
UMLS CUI [2]
C4270800
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Similar models

Eligibility Heart Disease NCT01994252

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Symptoms Heart failure New York Heart Association Classification
Item
patients with nyha class ii or iii hf symptoms (assessment in the last 3 months)
boolean
C1457887 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Permanent atrial fibrillation
Item
permanent af
boolean
C2586056 (UMLS CUI [1])
Therapy Optimal Heart failure
Item
optimal medical therapy for hf of at least 3 months (according to 2009 accf/aha and esc 2012 recommendations,)
boolean
C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Left ventricular ejection fraction
Item
lvef ≤ 35% (assessment in the last 6 months)
boolean
C0428772 (UMLS CUI [1])
Patient Appropriate ICD | Primary Prevention Sudden Cardiac Death | Secondary Prevention Sudden Cardiac Death
Item
candidacy for an icd for primary or secondary prevention of sudden cardiac death
boolean
C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C0162589 (UMLS CUI [1,3])
C0033144 (UMLS CUI [2,1])
C0085298 (UMLS CUI [2,2])
C0679699 (UMLS CUI [3,1])
C0085298 (UMLS CUI [3,2])
QRS duration | Left Bundle-Branch Block | Left Bundle-Branch Block Absent | QRS duration Paced
Item
qrs durations ≥ 130 ms when the qrs morphology is lbbb, or qrs durations ≥ 150 ms when the qrs morphology is non-lbbb or paced qrs
boolean
C0429025 (UMLS CUI [1])
C0023211 (UMLS CUI [2])
C0023211 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0429025 (UMLS CUI [4,1])
C2981711 (UMLS CUI [4,2])
Item Group
C0680251 (UMLS CUI)
inpatient | Heart Disease | Illness | intensive care Required
Item
in-hospital patients who have acute cardiac or non-cardiac illness that requires intensive care
boolean
C0021562 (UMLS CUI [1])
C0018799 (UMLS CUI [2])
C0221423 (UMLS CUI [3])
C0085559 (UMLS CUI [4,1])
C1514873 (UMLS CUI [4,2])
Inotropic agent Intravenous
Item
intra-venous inotropic agent in the last 4 days
boolean
C0304509 (UMLS CUI [1,1])
C1522726 (UMLS CUI [1,2])
Life Expectancy
Item
patients with a life expectancy of less than one year from non-cardiac cause.
boolean
C0023671 (UMLS CUI [1])
Heart Transplantation Expected
Item
expected to undergo cardiac transplantation within one year (status i)
boolean
C0018823 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Acute Coronary Syndrome | Myocardial Infarction
Item
acute coronary syndrome (including mi) < 4 weeks
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
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])
Valvular disease uncorrected
Item
uncorrected or uncorrectable primary valvular disease
boolean
C3258293 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Restrictive cardiomyopathy | Hypertrophic Cardiomyopathy | Cardiomyopathy Reversible
Item
restrictive, hypertrophic or reversible form of cardiomyopathy
boolean
C0007196 (UMLS CUI [1])
C0007194 (UMLS CUI [2])
C0878544 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
Lung disease Severe | Cor pulmonale
Item
severe primary pulmonary disease such as cor pulmonale
boolean
C0024115 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0034072 (UMLS CUI [2])
Tricuspid valve Prosthetic
Item
tricuspid prosthetic valve
boolean
C0040960 (UMLS CUI [1,1])
C0175649 (UMLS CUI [1,2])
Study Subject Participation Status | Clinical Trial Affecting Research data
Item
patients included in other clinical trial that will affect the objectives of this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0681873 (UMLS CUI [2,3])
Coronary revascularisation | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention
Item
coronary revascularization (cabg or pci) < 3 months
boolean
C0877341 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
ICD | CRT pacemaker
Item
patients with an existing icd or crt pacemaker
boolean
C0162589 (UMLS CUI [1])
C4270800 (UMLS CUI [2])
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