ID

23959

Description

Magna® Mitral Pericardial Bioprostheses Post-Approval Study Protocol; ODM derived from: https://clinicaltrials.gov/show/NCT00853632

Link

https://clinicaltrials.gov/show/NCT00853632

Keywords

Versions (1)
  1. 7/20/17 7/20/17 -
Uploaded on

July 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00853632

English

Eligibility Coronary Artery Disease NCT00853632

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
Description

Evaluation Preoperative | Replacement of mitral valve Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C1261322
UMLS CUI [1,2]
C0445204
UMLS CUI [2,1]
C0026268
UMLS CUI [2,2]
C0686904
the patient has signed and dated the subject informed consent form prior to surgery.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
the patient is expected to survive the surgery and be discharged.
Description

Operative Surgical Procedure Survival Expected | Patient Discharge Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0543467
UMLS CUI [1,2]
C0038952
UMLS CUI [1,3]
C1517001
UMLS CUI [2,1]
C0030685
UMLS CUI [2,2]
C1517001
the patient is geographically stable and agrees to attend follow-up assessments.
Description

Geographical environment Stable | Patient Available Clinical Study Follow-up

Data type

boolean

Alias
UMLS CUI [1,1]
C0565935
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0470187
UMLS CUI [2,3]
C3274571
the patient is 18 years or older.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
the patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
Description

Life threatening illness Life Expectancy Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C3846017
UMLS CUI [1,2]
C0023671
UMLS CUI [1,3]
C0439801
the patient presents with active endocarditis within the last 3 months.
Description

Endocarditis

Data type

boolean

Alias
UMLS CUI [1]
C0014118
the patient is pregnant or lactating.
Description

Pregnancy | Breast Feeding

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
the patient is an intravenous drug abuser.
Description

Intravenous Drug Abuse

Data type

boolean

Alias
UMLS CUI [1]
C0086181
the patient is currently a prison inmate.
Description

Prisoner

Data type

boolean

Alias
UMLS CUI [1]
C0033167
the patient is currently participating in a study of an investigational drug or device.
Description

Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C2346570
the patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
Description

Replacement of tricuspid valve Native Patient need for | Mechanical prosthetic tricuspid valve replacement Patient need for | Replacement of pulmonary valve Native Patient need for | Mechanical prosthetic pulmonary valve replacement Patient need for

Data type

boolean

Alias
UMLS CUI [1,1]
C0190119
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0396941
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0190129
UMLS CUI [3,2]
C0302891
UMLS CUI [3,3]
C0686904
UMLS CUI [4,1]
C0397031
UMLS CUI [4,2]
C0686904
the patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available carpentier-edwards perimount valve (i.e. models 2700, 2700tfx, 2800, 2800tfx, 2900, 3000, 3000tfx, 3300tfx)*.
Description

Replacement of aortic valve Native Patient need for | Mechanical prosthetic aortic valve replacement Patient need for | Aortic valve prosthesis Type

Data type

boolean

Alias
UMLS CUI [1,1]
C0003506
UMLS CUI [1,2]
C0302891
UMLS CUI [1,3]
C0686904
UMLS CUI [2,1]
C0396982
UMLS CUI [2,2]
C0686904
UMLS CUI [3,1]
C0182431
UMLS CUI [3,2]
C0332307
the patient was previously enrolled in the study.
Description

Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C2348568
the patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
Description

Aortic valve Operative Surgical Procedures | Tricuspid valve Operative Surgical Procedures | Pulmonary valve Operative Surgical Procedures | Implantation Valve Tissue Graft | Implantation Mechanical prosthetic valve In situ

Data type

boolean

Alias
UMLS CUI [1,1]
C0003501
UMLS CUI [1,2]
C0543467
UMLS CUI [2,1]
C0040960
UMLS CUI [2,2]
C0543467
UMLS CUI [3,1]
C0034086
UMLS CUI [3,2]
C0543467
UMLS CUI [4,1]
C0021107
UMLS CUI [4,2]
C1186983
UMLS CUI [4,3]
C0348047
UMLS CUI [5,1]
C0021107
UMLS CUI [5,2]
C4062429
UMLS CUI [5,3]
C0444498
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Similar models

Eligibility Coronary Artery Disease NCT00853632

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Evaluation Preoperative | Replacement of mitral valve Patient need for
Item
the patient requires, as indicated in the preoperative evaluation, a replacement mitral valve.
boolean
C1261322 (UMLS CUI [1,1])
C0445204 (UMLS CUI [1,2])
C0026268 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
Informed Consent
Item
the patient has signed and dated the subject informed consent form prior to surgery.
boolean
C0021430 (UMLS CUI [1])
Operative Surgical Procedure Survival Expected | Patient Discharge Expected
Item
the patient is expected to survive the surgery and be discharged.
boolean
C0543467 (UMLS CUI [1,1])
C0038952 (UMLS CUI [1,2])
C1517001 (UMLS CUI [1,3])
C0030685 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Geographical environment Stable | Patient Available Clinical Study Follow-up
Item
the patient is geographically stable and agrees to attend follow-up assessments.
boolean
C0565935 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0470187 (UMLS CUI [2,2])
C3274571 (UMLS CUI [2,3])
Age
Item
the patient is 18 years or older.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Life threatening illness Life Expectancy Limited
Item
the patient has any known non-cardiac life-threatening disease, which will limit the patient's life expectancy below 1 year.
boolean
C3846017 (UMLS CUI [1,1])
C0023671 (UMLS CUI [1,2])
C0439801 (UMLS CUI [1,3])
Endocarditis
Item
the patient presents with active endocarditis within the last 3 months.
boolean
C0014118 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
the patient is pregnant or lactating.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Intravenous Drug Abuse
Item
the patient is an intravenous drug abuser.
boolean
C0086181 (UMLS CUI [1])
Prisoner
Item
the patient is currently a prison inmate.
boolean
C0033167 (UMLS CUI [1])
Study Subject Participation Status | Investigational New Drugs | Investigational Medical Device
Item
the patient is currently participating in a study of an investigational drug or device.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C2346570 (UMLS CUI [3])
Replacement of tricuspid valve Native Patient need for | Mechanical prosthetic tricuspid valve replacement Patient need for | Replacement of pulmonary valve Native Patient need for | Mechanical prosthetic pulmonary valve replacement Patient need for
Item
the patient requires replacement of a native or prosthetic tricuspid or pulmonic valve.
boolean
C0190119 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0396941 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0190129 (UMLS CUI [3,1])
C0302891 (UMLS CUI [3,2])
C0686904 (UMLS CUI [3,3])
C0397031 (UMLS CUI [4,1])
C0686904 (UMLS CUI [4,2])
Replacement of aortic valve Native Patient need for | Mechanical prosthetic aortic valve replacement Patient need for | Aortic valve prosthesis Type
Item
the patient requires replacement of a native or prosthetic aortic valve with a prosthesis other than a commercially available carpentier-edwards perimount valve (i.e. models 2700, 2700tfx, 2800, 2800tfx, 2900, 3000, 3000tfx, 3300tfx)*.
boolean
C0003506 (UMLS CUI [1,1])
C0302891 (UMLS CUI [1,2])
C0686904 (UMLS CUI [1,3])
C0396982 (UMLS CUI [2,1])
C0686904 (UMLS CUI [2,2])
C0182431 (UMLS CUI [3,1])
C0332307 (UMLS CUI [3,2])
Study Subject Participation Status
Item
the patient was previously enrolled in the study.
boolean
C2348568 (UMLS CUI [1])
Aortic valve Operative Surgical Procedures | Tricuspid valve Operative Surgical Procedures | Pulmonary valve Operative Surgical Procedures | Implantation Valve Tissue Graft | Implantation Mechanical prosthetic valve In situ
Item
the patient has had prior aortic, tricuspid and/or pulmonary valve surgery, which included implantation of a bioprosthetic valve or mechanical valve that will remain in situ.
boolean
C0003501 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0040960 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
C0034086 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
C0021107 (UMLS CUI [4,1])
C1186983 (UMLS CUI [4,2])
C0348047 (UMLS CUI [4,3])
C0021107 (UMLS CUI [5,1])
C4062429 (UMLS CUI [5,2])
C0444498 (UMLS CUI [5,3])
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