ID

30822

Description

VIVID - Valvular and Ventricular Improvement Via iCoapsys Delivery - Feasibility Study; ODM derived from: https://clinicaltrials.gov/show/NCT00512005

Link

https://clinicaltrials.gov/show/NCT00512005

Keywords

Versions (1)
  1. 6/23/18 6/23/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

June 23, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Mitral Valve Regurgitation NCT00512005

English

Eligibility Mitral Valve Regurgitation NCT00512005

1 forms  
Criteria
Description

Criteria

grade 3 or 4 functional mitral valve regurgitation per 2d echocardiography.
Description

Functional mitral regurgitation Grade 2D Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0340369
UMLS CUI [1,2]
C0441800
UMLS CUI [1,3]
C0013524
nyha class ii and lvef greater than or equal to 25% or nyha class iii and lvef greater than or equal to 30%
Description

New York Heart Association Classification | Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2]
C0428772
key exclusion criteria:
Description

Exclusion Criteria Main

Data type

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
history of pericarditis.
Description

Pericarditis

Data type

boolean

Alias
UMLS CUI [1]
C0031046
creatinine > 2.2 at the time of the procedure
Description

Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1]
C0201976
inr > 1.8 at the time of the procedure
Description

INR

Data type

boolean

Alias
UMLS CUI [1]
C0525032
prior pericardial intervention (including cabg, pericardiotomy or pericardiocentesis).
Description

Intervention Pericardial | Coronary Artery Bypass Surgery | Pericardiotomy | Pericardiocentesis

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0442031
UMLS CUI [2]
C0010055
UMLS CUI [3]
C0242427
UMLS CUI [4]
C0191234
any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
Description

Interventional procedure endovascular | Operative Surgical Procedures endovascular | Status pre- Placement of stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C0524425
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C0524425
UMLS CUI [3,1]
C0332152
UMLS CUI [3,2]
C0522776
any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
Description

Interventional procedure Planned | Operative Surgical Procedures Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0184661
UMLS CUI [1,2]
C1301732
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1301732
open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
Description

Medical contraindication Thoracic Surgical Procedures Open | Acute respiratory distress | Endocarditis | Myocarditis

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0524832
UMLS CUI [1,3]
C0175566
UMLS CUI [2]
C0748355
UMLS CUI [3]
C0014118
UMLS CUI [4]
C0027059
structural abnormality of the mitral valve
Description

Abnormality of the mitral valve structural

Data type

boolean

Alias
UMLS CUI [1,1]
C4025759
UMLS CUI [1,2]
C0678594
valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
Description

Valvular disease Resulting in Aortic Valve Insufficiency | Valvular disease Resulting in Aortic Valve Stenosis | Valvular disease Resulting in Pulmonary Valve Insufficiency | Valvular disease Resulting in Pulmonary Valve Stenosis | Valvular disease Resulting in Tricuspid Valve Insufficiency | Valvular disease Resulting in Tricuspid Valve Stenosis | Intervention Required

Data type

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0332294
UMLS CUI [1,3]
C0003504
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0332294
UMLS CUI [2,3]
C0003507
UMLS CUI [3,1]
C3258293
UMLS CUI [3,2]
C0332294
UMLS CUI [3,3]
C0034088
UMLS CUI [4,1]
C3258293
UMLS CUI [4,2]
C0332294
UMLS CUI [4,3]
C0034089
UMLS CUI [5,1]
C3258293
UMLS CUI [5,2]
C0332294
UMLS CUI [5,3]
C0040961
UMLS CUI [6,1]
C3258293
UMLS CUI [6,2]
C0332294
UMLS CUI [6,3]
C0040963
UMLS CUI [7,1]
C0184661
UMLS CUI [7,2]
C1514873
pericardial effusion >5 mm via echocardiography.
Description

Pericardial effusion Extent Echocardiography

Data type

boolean

Alias
UMLS CUI [1,1]
C0031039
UMLS CUI [1,2]
C0439792
UMLS CUI [1,3]
C0013516
posterior wall end-diastolic dimension >1.3 cm.
Description

Posterior wall end diastolic Dimension

Data type

boolean

Alias
UMLS CUI [1,1]
C0442071
UMLS CUI [1,2]
C0442709
UMLS CUI [1,3]
C0439534
left ventricular end diastolic diameter > 7.0 cm.
Description

Left ventricle end diastolic Diameter

Data type

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C0442709
UMLS CUI [1,3]
C1301886
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Similar models

Eligibility Mitral Valve Regurgitation NCT00512005

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Functional mitral regurgitation Grade 2D Echocardiography
Item
grade 3 or 4 functional mitral valve regurgitation per 2d echocardiography.
boolean
C0340369 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
C0013524 (UMLS CUI [1,3])
New York Heart Association Classification | Left ventricular ejection fraction
Item
nyha class ii and lvef greater than or equal to 25% or nyha class iii and lvef greater than or equal to 30%
boolean
C1275491 (UMLS CUI [1])
C0428772 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Pericarditis
Item
history of pericarditis.
boolean
C0031046 (UMLS CUI [1])
Creatinine measurement, serum
Item
creatinine > 2.2 at the time of the procedure
boolean
C0201976 (UMLS CUI [1])
INR
Item
inr > 1.8 at the time of the procedure
boolean
C0525032 (UMLS CUI [1])
Intervention Pericardial | Coronary Artery Bypass Surgery | Pericardiotomy | Pericardiocentesis
Item
prior pericardial intervention (including cabg, pericardiotomy or pericardiocentesis).
boolean
C0184661 (UMLS CUI [1,1])
C0442031 (UMLS CUI [1,2])
C0010055 (UMLS CUI [2])
C0242427 (UMLS CUI [3])
C0191234 (UMLS CUI [4])
Interventional procedure endovascular | Operative Surgical Procedures endovascular | Status pre- Placement of stent
Item
any endovascular therapeutic interventional or surgical procedure performed within 30 days prior to the index procedure (e.g., stent placement).
boolean
C0184661 (UMLS CUI [1,1])
C0524425 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C0524425 (UMLS CUI [2,2])
C0332152 (UMLS CUI [3,1])
C0522776 (UMLS CUI [3,2])
Interventional procedure Planned | Operative Surgical Procedures Planned
Item
any planned therapeutic interventional or surgical procedure planned within 30 days following the index procedure
boolean
C0184661 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
C0543467 (UMLS CUI [2,1])
C1301732 (UMLS CUI [2,2])
Medical contraindication Thoracic Surgical Procedures Open | Acute respiratory distress | Endocarditis | Myocarditis
Item
open chest surgery contraindication (e.g., acute respiratory distress, endocarditis, myocarditis).
boolean
C1301624 (UMLS CUI [1,1])
C0524832 (UMLS CUI [1,2])
C0175566 (UMLS CUI [1,3])
C0748355 (UMLS CUI [2])
C0014118 (UMLS CUI [3])
C0027059 (UMLS CUI [4])
Abnormality of the mitral valve structural
Item
structural abnormality of the mitral valve
boolean
C4025759 (UMLS CUI [1,1])
C0678594 (UMLS CUI [1,2])
Valvular disease Resulting in Aortic Valve Insufficiency | Valvular disease Resulting in Aortic Valve Stenosis | Valvular disease Resulting in Pulmonary Valve Insufficiency | Valvular disease Resulting in Pulmonary Valve Stenosis | Valvular disease Resulting in Tricuspid Valve Insufficiency | Valvular disease Resulting in Tricuspid Valve Stenosis | Intervention Required
Item
valve disease resulting in insufficiency or stenosis of the aortic, pulmonary or tricuspid valve requiring intervention.
boolean
C3258293 (UMLS CUI [1,1])
C0332294 (UMLS CUI [1,2])
C0003504 (UMLS CUI [1,3])
C3258293 (UMLS CUI [2,1])
C0332294 (UMLS CUI [2,2])
C0003507 (UMLS CUI [2,3])
C3258293 (UMLS CUI [3,1])
C0332294 (UMLS CUI [3,2])
C0034088 (UMLS CUI [3,3])
C3258293 (UMLS CUI [4,1])
C0332294 (UMLS CUI [4,2])
C0034089 (UMLS CUI [4,3])
C3258293 (UMLS CUI [5,1])
C0332294 (UMLS CUI [5,2])
C0040961 (UMLS CUI [5,3])
C3258293 (UMLS CUI [6,1])
C0332294 (UMLS CUI [6,2])
C0040963 (UMLS CUI [6,3])
C0184661 (UMLS CUI [7,1])
C1514873 (UMLS CUI [7,2])
Pericardial effusion Extent Echocardiography
Item
pericardial effusion >5 mm via echocardiography.
boolean
C0031039 (UMLS CUI [1,1])
C0439792 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])
Posterior wall end diastolic Dimension
Item
posterior wall end-diastolic dimension >1.3 cm.
boolean
C0442071 (UMLS CUI [1,1])
C0442709 (UMLS CUI [1,2])
C0439534 (UMLS CUI [1,3])
Left ventricle end diastolic Diameter
Item
left ventricular end diastolic diameter > 7.0 cm.
boolean
C0225897 (UMLS CUI [1,1])
C0442709 (UMLS CUI [1,2])
C1301886 (UMLS CUI [1,3])
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