ID

39472

Description

Monitoring of Hemodynamics in Heart Failure Patients by Intracardiac Impedance Measurement; ODM derived from: https://clinicaltrials.gov/show/NCT01711281

Link

https://clinicaltrials.gov/show/NCT01711281

Keywords

Versions (1)
  1. 1/14/20 1/14/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

January 14, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01711281

English

Eligibility Heart Failure NCT01711281

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
de novo crt-patients
Description

Cardiac Resynchronization Therapy de novo

Data type

boolean

Alias
UMLS CUI [1,1]
C1167956
UMLS CUI [1,2]
C1515568
planned implantation with a lumax 740 hf-t device, a bipolar lv-lead and a true bipolar rv-lead
Description

Implantation of CRT-D Specified Planned | implantable cardioverter-defibrillator left ventricular lead Bipolar | implantable cardioverter-defibrillator right ventricular lead Bipolar

Data type

boolean

Alias
UMLS CUI [1,1]
C1135480
UMLS CUI [1,2]
C0205369
UMLS CUI [1,3]
C1301732
UMLS CUI [2,1]
C2048278
UMLS CUI [2,2]
C0443156
UMLS CUI [3,1]
C2048371
UMLS CUI [3,2]
C0443156
nyha class ii or iii
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
qrs ≥ 150 ms
Description

QRS duration

Data type

boolean

Alias
UMLS CUI [1]
C0429025
lvef between 15% and 35%
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
lvedd ≥ 55 mm
Description

Left ventricular end-diastolic dimension

Data type

boolean

Alias
UMLS CUI [1]
C1142231
evaluable echo measurements
Description

Echocardiography

Data type

boolean

Alias
UMLS CUI [1]
C0013516
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
persistent or permanent atrial fibrillation
Description

Persistent atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C2586056
heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
Description

Cardiac Surgery | Cardiac Surgery Planned | Status post Heart Transplantation | Patient on waiting list Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1]
C0018821
UMLS CUI [2,1]
C0018821
UMLS CUI [2,2]
C1301732
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0018823
UMLS CUI [4,1]
C0422768
UMLS CUI [4,2]
C0018823
non-ambulatory patients
Description

Lacking Able to walk

Data type

boolean

Alias
UMLS CUI [1,1]
C0332268
UMLS CUI [1,2]
C2712089
chronic renal dialysis
Description

Dialysis chronic

Data type

boolean

Alias
UMLS CUI [1]
C0743165
life expectancy less than 1 year due to a non-cardiac disease
Description

Life Expectancy Due to Disease | Exception Heart Disease

Data type

boolean

Alias
UMLS CUI [1,1]
C0023671
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0012634
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0018799
age < 18 years and/or limited contractual capability
Description

Age | Legal capacity Limited

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2,1]
C0683673
UMLS CUI [2,2]
C0439801
addiction to alcohol, medical drugs or illegal drugs
Description

Alcoholic Intoxication, Chronic | Drug Addiction | Illicit Drug Addiction

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2,1]
C0013227
UMLS CUI [2,2]
C0085281
UMLS CUI [3,1]
C0086190
UMLS CUI [3,2]
C0085281
pregnant or breast-feeding women
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
participation in another clinical trial
Description

Study Subject Participation Status | Clinical Trial

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0008976
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Similar models

Eligibility Heart Failure NCT01711281

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Cardiac Resynchronization Therapy de novo
Item
de novo crt-patients
boolean
C1167956 (UMLS CUI [1,1])
C1515568 (UMLS CUI [1,2])
Implantation of CRT-D Specified Planned | implantable cardioverter-defibrillator left ventricular lead Bipolar | implantable cardioverter-defibrillator right ventricular lead Bipolar
Item
planned implantation with a lumax 740 hf-t device, a bipolar lv-lead and a true bipolar rv-lead
boolean
C1135480 (UMLS CUI [1,1])
C0205369 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
C2048278 (UMLS CUI [2,1])
C0443156 (UMLS CUI [2,2])
C2048371 (UMLS CUI [3,1])
C0443156 (UMLS CUI [3,2])
New York Heart Association Classification
Item
nyha class ii or iii
boolean
C1275491 (UMLS CUI [1])
QRS duration
Item
qrs ≥ 150 ms
boolean
C0429025 (UMLS CUI [1])
Left ventricular ejection fraction
Item
lvef between 15% and 35%
boolean
C0428772 (UMLS CUI [1])
Left ventricular end-diastolic dimension
Item
lvedd ≥ 55 mm
boolean
C1142231 (UMLS CUI [1])
Echocardiography
Item
evaluable echo measurements
boolean
C0013516 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Persistent atrial fibrillation | Permanent atrial fibrillation
Item
persistent or permanent atrial fibrillation
boolean
C2585653 (UMLS CUI [1])
C2586056 (UMLS CUI [2])
Cardiac Surgery | Cardiac Surgery Planned | Status post Heart Transplantation | Patient on waiting list Heart Transplantation
Item
heart surgery within the previous 3 months or planned for the time of study participation; post-heart transplantation or listed for heart transplantation
boolean
C0018821 (UMLS CUI [1])
C0018821 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
C0231290 (UMLS CUI [3,1])
C0018823 (UMLS CUI [3,2])
C0422768 (UMLS CUI [4,1])
C0018823 (UMLS CUI [4,2])
Lacking Able to walk
Item
non-ambulatory patients
boolean
C0332268 (UMLS CUI [1,1])
C2712089 (UMLS CUI [1,2])
Dialysis chronic
Item
chronic renal dialysis
boolean
C0743165 (UMLS CUI [1])
Life Expectancy Due to Disease | Exception Heart Disease
Item
life expectancy less than 1 year due to a non-cardiac disease
boolean
C0023671 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0012634 (UMLS CUI [1,3])
C1705847 (UMLS CUI [2,1])
C0018799 (UMLS CUI [2,2])
Age | Legal capacity Limited
Item
age < 18 years and/or limited contractual capability
boolean
C0001779 (UMLS CUI [1])
C0683673 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Alcoholic Intoxication, Chronic | Drug Addiction | Illicit Drug Addiction
Item
addiction to alcohol, medical drugs or illegal drugs
boolean
C0001973 (UMLS CUI [1])
C0013227 (UMLS CUI [2,1])
C0085281 (UMLS CUI [2,2])
C0086190 (UMLS CUI [3,1])
C0085281 (UMLS CUI [3,2])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Study Subject Participation Status | Clinical Trial
Item
participation in another clinical trial
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
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