ID

30817

Description

Safety and Efficacy Study of the PTMA Device to Reduce Mitral Valve Regurgitation in Patients With Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00815386

Link

https://clinicaltrials.gov/show/NCT00815386

Keywords

Versions (1)
  1. 6/22/18 6/22/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 22, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Mitral Regurgitation NCT00815386

English

Eligibility Mitral Regurgitation NCT00815386

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient has moderate functional mr: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 ml/beat or regurgitant fraction >/= 30%
Description

Mitral Valve Insufficiency Functional Moderate | Effective Regurgitant Orifice Area | Regurgitant volume | Regurgitant fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0205245
UMLS CUI [1,3]
C0205081
UMLS CUI [2]
C4264252
UMLS CUI [3]
C0946338
UMLS CUI [4]
C1302309
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
lv dysfunction (25% < lvef < 50% by echocardiography) or dilated mitral annulus > 30mm
Description

Ventricular Dysfunction, Left | Left ventricular ejection fraction Echocardiography | Dilatation of mitral annulus

Data type

boolean

Alias
UMLS CUI [1]
C0242698
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0013516
UMLS CUI [3]
C0344765
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
mr of organic origin
Description

Mitral Valve Insufficiency Organ Origin

Data type

boolean

Alias
UMLS CUI [1,1]
C0026266
UMLS CUI [1,2]
C0178784
UMLS CUI [1,3]
C0439659
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

Distance in the 6-minute walk test below normal range

Data type

boolean

Alias
UMLS CUI [1]
C4062419
significant left main stenosis or proximal circumflex stent
Description

Left main coronary artery stenosis | Proximal Circumflex Artery Stent

Data type

boolean

Alias
UMLS CUI [1]
C2062905
UMLS CUI [2,1]
C3640701
UMLS CUI [2,2]
C0038257
indication of non-patent cso or discontinuous cs-gcv-aiv
Description

Indication Coronary sinus ostium Non-patent | Coronary sinus Great cardiac vein Anterior interventricular vein Discontinuous

Data type

boolean

Alias
UMLS CUI [1,1]
C3146298
UMLS CUI [1,2]
C1305179
UMLS CUI [1,3]
C0442742
UMLS CUI [2,1]
C0456944
UMLS CUI [2,2]
C1280939
UMLS CUI [2,3]
C0933502
UMLS CUI [2,4]
C0439599
bi-ventricular with leads in cs or other devices impeding device placement
Description

Biventricular Pacing Devices Leads Coronary sinus | Interference Implantation procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1322649
UMLS CUI [1,2]
C0181586
UMLS CUI [1,3]
C0456944
UMLS CUI [2,1]
C0521102
UMLS CUI [2,2]
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

Corticosteroid use chronic | Exception Prednisone Dosage Arthritis

Data type

boolean

Alias
UMLS CUI [1,1]
C0239126
UMLS CUI [1,2]
C0205191
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0032952
UMLS CUI [2,3]
C0178602
UMLS CUI [2,4]
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 Mitral Regurgitation NCT00815386

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Mitral Valve Insufficiency Functional Moderate | Effective Regurgitant Orifice Area | Regurgitant volume | Regurgitant fraction
Item
patient has moderate functional mr: regurgitant orifice area >/= 0.20cm2 or regurgitant volume >/= 30 ml/beat or regurgitant fraction >/= 30%
boolean
C0026266 (UMLS CUI [1,1])
C0205245 (UMLS CUI [1,2])
C0205081 (UMLS CUI [1,3])
C4264252 (UMLS CUI [2])
C0946338 (UMLS CUI [3])
C1302309 (UMLS CUI [4])
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])
Ventricular Dysfunction, Left | Left ventricular ejection fraction Echocardiography | Dilatation of mitral annulus
Item
lv dysfunction (25% < lvef < 50% by echocardiography) or dilated mitral annulus > 30mm
boolean
C0242698 (UMLS CUI [1])
C0428772 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0344765 (UMLS CUI [3])
Item Group
C0680251 (UMLS CUI)
Mitral Valve Insufficiency Organ Origin
Item
mr of organic origin
boolean
C0026266 (UMLS CUI [1,1])
C0178784 (UMLS CUI [1,2])
C0439659 (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])
Distance in the 6-minute walk test below normal range
Item
inability to walk a minimum of 100 meters in 6 minutes
boolean
C4062419 (UMLS CUI [1])
Left main coronary artery stenosis | Proximal Circumflex Artery Stent
Item
significant left main stenosis or proximal circumflex stent
boolean
C2062905 (UMLS CUI [1])
C3640701 (UMLS CUI [2,1])
C0038257 (UMLS CUI [2,2])
Indication Coronary sinus ostium Non-patent | Coronary sinus Great cardiac vein Anterior interventricular vein Discontinuous
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])
C0456944 (UMLS CUI [2,1])
C1280939 (UMLS CUI [2,2])
C0933502 (UMLS CUI [2,3])
C0439599 (UMLS CUI [2,4])
Biventricular Pacing Devices Leads Coronary sinus | Interference Implantation procedure
Item
bi-ventricular with leads in cs or other devices impeding device placement
boolean
C1322649 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C0456944 (UMLS CUI [1,3])
C0521102 (UMLS CUI [2,1])
C0021107 (UMLS CUI [2,2])
Aortic valve disorder Severe
Item
severe aortic valvular disease
boolean
C1260873 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
Corticosteroid use chronic | Exception Prednisone Dosage Arthritis
Item
chronic corticosteroid use other than < 20mg prednisone for arthritis
boolean
C0239126 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C1705847 (UMLS CUI [2,1])
C0032952 (UMLS CUI [2,2])
C0178602 (UMLS CUI [2,3])
C0003864 (UMLS CUI [2,4])
Comorbidity Significant
Item
significant co-morbidities
boolean
C0009488 (UMLS CUI [1,1])
C0750502 (UMLS CUI [1,2])
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