ID

29462

Description

Study of Safety and Efficacy of the Percutaneous Reduction of Mitral Valve Regurgitation in Heart Failure Patients; ODM derived from: https://clinicaltrials.gov/show/NCT00787293

Link

https://clinicaltrials.gov/show/NCT00787293

Keywords

Versions (1)
  1. 3/27/18 3/27/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 27, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00787293

English

Eligibility Heart Failure NCT00787293

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
functional mr 2+ - 4+
Description

Mitral Regurgitation Grade

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0441800
symptomatic heart failure, nyha class ii to iv
Description

Heart failure Symptomatic New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C1275491
lvef > 25% or < 50% or dilated mitral annulus > 30mm
Description

Left ventricular ejection fraction | Dilatation of mitral annulus

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2]
C0344765
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mr of organic origin
Description

Mitral Regurgitation Origin organic

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0439659
UMLS CUI [1,3]
C0747055
severe mitral leaflet tethering
Description

Leaflet of mitral valve Tethering Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C0225949
UMLS CUI [1,2]
C0577538
UMLS CUI [1,3]
C0205082
history of mi or pci within 60 days of study procedure
Description

Myocardial Infarction | Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2]
C1532338
inability to walk a minimum of 100 meters in 6 minutes
Description

6 Minute Walk Functional Test Unsuccessful

Data type

boolean

Alias
UMLS CUI [1,1]
C3900196
UMLS CUI [1,2]
C1272705
significant left main stenosis or proximal circumflex stent
Description

Left main coronary artery stenosis | Stent in circumflex branch of left coronary artery Proximal

Data type

boolean

Alias
UMLS CUI [1]
C2062905
UMLS CUI [2,1]
C3839305
UMLS CUI [2,2]
C0205107
indication of non-patent cso or discontinuous cs-gcv-aiv
Description

Indication Coronary sinus ostium Non-patent | Other Coding

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1305179
UMLS CUI [1,3]
C0442742
UMLS CUI [2]
C3846158
bi-ventricular with leads in cs or other devices impeding device placement
Description

Medical Devices Preventing Implantation procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0021107
severe aortic valvular disease
Description

Aortic valve disorder Severe

Data type

boolean

Alias
UMLS CUI [1,1]
C1260873
UMLS CUI [1,2]
C0205082
chronic corticosteroid use other than < 20mg prednisone for arthritis
Description

Adrenal Cortex Hormones chronic | Exception Prednisone Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0001617
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0003864
significant co-morbidities
Description

Comorbidity Significant

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0750502
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Similar models

Eligibility Heart Failure NCT00787293

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mitral Regurgitation Grade
Item
functional mr 2+ - 4+
boolean
C0026266 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Heart failure Symptomatic New York Heart Association Classification
Item
symptomatic heart failure, nyha class ii to iv
boolean
C0018801 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
Left ventricular ejection fraction | Dilatation of mitral annulus
Item
lvef > 25% or < 50% or dilated mitral annulus > 30mm
boolean
C0428772 (UMLS CUI [1])
C0344765 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Mitral Regurgitation Origin organic
Item
mr of organic origin
boolean
C0026266 (UMLS CUI [1,1])
C0439659 (UMLS CUI [1,2])
C0747055 (UMLS CUI [1,3])
Leaflet of mitral valve Tethering Severe
Item
severe mitral leaflet tethering
boolean
C0225949 (UMLS CUI [1,1])
C0577538 (UMLS CUI [1,2])
C0205082 (UMLS CUI [1,3])
Myocardial Infarction | Percutaneous Coronary Intervention
Item
history of mi or pci within 60 days of study procedure
boolean
C0027051 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
6 Minute Walk Functional Test Unsuccessful
Item
inability to walk a minimum of 100 meters in 6 minutes
boolean
C3900196 (UMLS CUI [1,1])
C1272705 (UMLS CUI [1,2])
Left main coronary artery stenosis | Stent in circumflex branch of left coronary artery Proximal
Item
significant left main stenosis or proximal circumflex stent
boolean
C2062905 (UMLS CUI [1])
C3839305 (UMLS CUI [2,1])
C0205107 (UMLS CUI [2,2])
Indication Coronary sinus ostium Non-patent | Other Coding
Item
indication of non-patent cso or discontinuous cs-gcv-aiv
boolean
C3146298 (UMLS CUI [1,1])
C1305179 (UMLS CUI [1,2])
C0442742 (UMLS CUI [1,3])
C3846158 (UMLS CUI [2])
Medical Devices Preventing Implantation procedure
Item
bi-ventricular with leads in cs or other devices impeding device placement
boolean
C0025080 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0021107 (UMLS CUI [1,3])
Aortic valve disorder Severe
Item
severe aortic valvular disease
boolean
C1260873 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Adrenal Cortex Hormones chronic | Exception Prednisone Arthritis
Item
chronic corticosteroid use other than < 20mg prednisone for arthritis
boolean
C0001617 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0003864 (UMLS CUI [2,3])
Comorbidity Significant
Item
significant co-morbidities
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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