ID

30822

Beschrijving

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

Link

https://clinicaltrials.gov/show/NCT00512005

Trefwoorden

Versies (1)
  1. 23-06-18 23-06-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

23 juni 2018

DOI

Voor een aanvraag inloggen.

Licentie

Creative Commons BY 4.0
Model Commentaren :

Hier kunt u commentaar leveren op het model. U kunt de tekstballonnen bij de itemgroepen en items gebruiken om er specifiek commentaar op te geven.

Terug naar het model Commentaren
Itemgroep Commentaren voor :

Item Commentaren voor :

U moet ingelogd zijn om formulieren te downloaden. AUB inloggen of schrijf u gratis in.

Eligibility Mitral Valve Regurgitation NCT00512005

Engels

Eligibility Mitral Valve Regurgitation NCT00512005

1 Formulieren  
Criteria
Beschrijving

Criteria

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

Functional mitral regurgitation Grade 2D Echocardiography

Datatype

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%
Beschrijving

New York Heart Association Classification | Left ventricular ejection fraction

Datatype

boolean

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

Exclusion Criteria Main

Datatype

boolean

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

Pericarditis

Datatype

boolean

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

Creatinine measurement, serum

Datatype

boolean

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

INR

Datatype

boolean

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

Intervention Pericardial | Coronary Artery Bypass Surgery | Pericardiotomy | Pericardiocentesis

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

Interventional procedure Planned | Operative Surgical Procedures Planned

Datatype

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).
Beschrijving

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

Datatype

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
Beschrijving

Abnormality of the mitral valve structural

Datatype

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.
Beschrijving

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

Datatype

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.
Beschrijving

Pericardial effusion Extent Echocardiography

Datatype

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.
Beschrijving

Posterior wall end diastolic Dimension

Datatype

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.
Beschrijving

Left ventricle end diastolic Diameter

Datatype

boolean

Alias
UMLS CUI [1,1]
C0225897
UMLS CUI [1,2]
C0442709
UMLS CUI [1,3]
C1301886
Terug naar het begin van de pagina

Similar models

Eligibility Mitral Valve Regurgitation NCT00512005

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
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])
Terug naar het begin van de pagina 

Contact

Gebruik dit formulier voor feedback, vragen en verbeteringsvoorstellen.

Velden gemarkeerd met een * zijn verplicht.

Help

Do you need help on how to use the search function? Please watch the corresponding tutorial video for more details and learn how to use the search function most efficiently.

Watch Tutorial