ID

39460

Beskrivning

Feasibility Trial of the DC Devices Interatrial Septal Device (IASD) System; ODM derived from: https://clinicaltrials.gov/show/NCT01570517

Länk

https://clinicaltrials.gov/show/NCT01570517

Nyckelord

  1. 2020-01-12 2020-01-12 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

12 januari 2020

DOI

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Licens

Creative Commons BY 4.0

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Eligibility Heart Failure NCT01570517

Eligibility Heart Failure NCT01570517

Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
clinical diagnosis of hfpef
Beskrivning

Heart failure with preserved ejection fraction [HFpEF]

Datatyp

boolean

Alias
UMLS CUI [1]
C4509226
ejection fraction of at least 45%
Beskrivning

Cardiac ejection fraction

Datatyp

boolean

Alias
UMLS CUI [1]
C0232174
imaging and hemodynamic evidence of hfpef
Beskrivning

HFpEF Imaging | HFpEF Evidence Hemodynamic

Datatyp

boolean

Alias
UMLS CUI [1,1]
C4509226
UMLS CUI [1,2]
C0011923
UMLS CUI [2,1]
C4509226
UMLS CUI [2,2]
C3887511
UMLS CUI [2,3]
C0019010
history of exercise intolerance
Beskrivning

Impaired exercise tolerance

Datatyp

boolean

Alias
UMLS CUI [1]
C0424551
symptomatic despite optimal medical management
Beskrivning

Symptomatic | Disease Management Optimal

Datatyp

boolean

Alias
UMLS CUI [1]
C0231220
UMLS CUI [2,1]
C0376636
UMLS CUI [2,2]
C2698651
signed study specific informed consent
Beskrivning

Informed Consent

Datatyp

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
history of thromboembolic events
Beskrivning

Thromboembolism

Datatyp

boolean

Alias
UMLS CUI [1]
C0040038
significant structural heart disease or coronary artery disease
Beskrivning

Structural disorder of heart | Coronary Artery Disease

Datatyp

boolean

Alias
UMLS CUI [1]
C1290384
UMLS CUI [2]
C1956346
contraindicated to study required medication
Beskrivning

Medical contraindication Investigational New Drugs

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0013230
right ventricular dysfunction
Beskrivning

Ventricular Dysfunction, Right

Datatyp

boolean

Alias
UMLS CUI [1]
C0242707
history of greater than mild restrictive or obstructive lung disease
Beskrivning

Restrictive lung disease Moderate | Obstructive Lung Disease Moderate | Restrictive lung disease Severe | Obstructive Lung Disease Severe

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0085581
UMLS CUI [1,2]
C0205081
UMLS CUI [2,1]
C0600260
UMLS CUI [2,2]
C0205081
UMLS CUI [3,1]
C0085581
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0600260
UMLS CUI [4,2]
C0205082
life expectancy less than one year for non-cardiovascular reasons
Beskrivning

Life Expectancy | Absence Etiology Cardiovascular

Datatyp

boolean

Alias
UMLS CUI [1]
C0023671
UMLS CUI [2,1]
C0332197
UMLS CUI [2,2]
C0015127
UMLS CUI [2,3]
C3887460
known or suspected allergy to implant material
Beskrivning

Hypersensitivity Implant material | Hypersensitivity Suspected Implant material

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0440216
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0750491
UMLS CUI [2,3]
C0440216
fertile women
Beskrivning

Childbearing Potential

Datatyp

boolean

Alias
UMLS CUI [1]
C3831118

Similar models

Eligibility Heart Failure NCT01570517

Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Heart failure with preserved ejection fraction [HFpEF]
Item
clinical diagnosis of hfpef
boolean
C4509226 (UMLS CUI [1])
Cardiac ejection fraction
Item
ejection fraction of at least 45%
boolean
C0232174 (UMLS CUI [1])
HFpEF Imaging | HFpEF Evidence Hemodynamic
Item
imaging and hemodynamic evidence of hfpef
boolean
C4509226 (UMLS CUI [1,1])
C0011923 (UMLS CUI [1,2])
C4509226 (UMLS CUI [2,1])
C3887511 (UMLS CUI [2,2])
C0019010 (UMLS CUI [2,3])
Impaired exercise tolerance
Item
history of exercise intolerance
boolean
C0424551 (UMLS CUI [1])
Symptomatic | Disease Management Optimal
Item
symptomatic despite optimal medical management
boolean
C0231220 (UMLS CUI [1])
C0376636 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
Informed Consent
Item
signed study specific informed consent
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Thromboembolism
Item
history of thromboembolic events
boolean
C0040038 (UMLS CUI [1])
Structural disorder of heart | Coronary Artery Disease
Item
significant structural heart disease or coronary artery disease
boolean
C1290384 (UMLS CUI [1])
C1956346 (UMLS CUI [2])
Medical contraindication Investigational New Drugs
Item
contraindicated to study required medication
boolean
C1301624 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
Ventricular Dysfunction, Right
Item
right ventricular dysfunction
boolean
C0242707 (UMLS CUI [1])
Restrictive lung disease Moderate | Obstructive Lung Disease Moderate | Restrictive lung disease Severe | Obstructive Lung Disease Severe
Item
history of greater than mild restrictive or obstructive lung disease
boolean
C0085581 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0600260 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C0085581 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0600260 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
Life Expectancy | Absence Etiology Cardiovascular
Item
life expectancy less than one year for non-cardiovascular reasons
boolean
C0023671 (UMLS CUI [1])
C0332197 (UMLS CUI [2,1])
C0015127 (UMLS CUI [2,2])
C3887460 (UMLS CUI [2,3])
Hypersensitivity Implant material | Hypersensitivity Suspected Implant material
Item
known or suspected allergy to implant material
boolean
C0020517 (UMLS CUI [1,1])
C0440216 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0440216 (UMLS CUI [2,3])
Childbearing Potential
Item
fertile women
boolean
C3831118 (UMLS CUI [1])

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