ID

36410

Description

CARILLON Mitral Contour System® for Reducing Functional Mitral Regurgitation; ODM derived from: https://clinicaltrials.gov/show/NCT02325830

Link

https://clinicaltrials.gov/show/NCT02325830

Keywords

Versions (1)
  1. 5/12/19 5/12/19 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

May 12, 2019

DOI

To request one please log in.

License

Creative Commons BY 4.0
Model comments :

You can comment on the data model here. Via the speech bubbles at the itemgroups and items you can add comments to those specificially.

Back to model comments
Itemgroup comments for :

Item comments for :

In order to download data models you must be logged in. Please log in or register for free.

Eligibility Mitral Valve Insufficiency NCT02325830

English

Eligibility Mitral Valve Insufficiency NCT02325830

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
diagnosis of dilated ischemic or non-ischemic cardiomyopathy
Description

Dilated ischemic cardiomyopathy | Non-ischemic dilated cardiomyopathy

Data type

boolean

Alias
UMLS CUI [1]
C2063324
UMLS CUI [2]
C1168330
functional mitral regurgitation: 2+ (moderate), 3+ (moderate/severe), or 4+ (severe)
Description

Mitral Valve Insufficiency | Mitral Valve Insufficiency Moderate | Mitral valve regurgitation, moderate to severe | Mitral Valve Insufficiency Severe

Data type

boolean

Alias
UMLS CUI [1]
C0026266
UMLS CUI [2,1]
C0026266
UMLS CUI [2,2]
C0205081
UMLS CUI [3]
C4478243
UMLS CUI [4,1]
C0026266
UMLS CUI [4,2]
C0205082
new york heart association (nyha) ii, iii, or iv
Description

New York Heart Association Classification

Data type

boolean

Alias
UMLS CUI [1]
C1275491
six minute walk distance of at least 150 meters and no farther than 450 meters
Description

6-Minute Walk Test Meter

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C0475209
left ventricular ejection fraction ≤ 40 %
Description

Left ventricular ejection fraction

Data type

boolean

Alias
UMLS CUI [1]
C0428772
lv end diastolic dimension (lvedd) >55mm or lvedd/body surface area (bsa) > 3.0cm/m2
Description

Left ventricular end-diastolic dimension | Left ventricular end-diastolic dimension Body Surface Area

Data type

boolean

Alias
UMLS CUI [1]
C1142231
UMLS CUI [2,1]
C1142231
UMLS CUI [2,2]
C0005902
stable heart failure medication regimen for at least three (3) months prior to index procedure
Description

Pharmacotherapy Stable Heart failure

Data type

boolean

Alias
UMLS CUI [1,1]
C0013216
UMLS CUI [1,2]
C0205360
UMLS CUI [1,3]
C0018801
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
Description

Hospitalization Due to Myocardial Infarction | Hospitalization Due to Coronary Artery Bypass Surgery | Hospitalization Due to Unstable Angina

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0027051
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0010055
UMLS CUI [3,1]
C0019993
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0002965
hospitalization in the past 30 days for coronary angioplasty or stent placement
Description

Hospitalization Due to Coronary angioplasty | Hospitalization Due to Placement of stent

Data type

boolean

Alias
UMLS CUI [1,1]
C0019993
UMLS CUI [1,2]
C0678226
UMLS CUI [1,3]
C0190211
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0678226
UMLS CUI [2,3]
C0522776
subjects expected to require any cardiac surgery within one (1) year
Description

Cardiac Surgery procedure Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1517001
subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
Description

Percutaneous Coronary Intervention Expected

Data type

boolean

Alias
UMLS CUI [1,1]
C1532338
UMLS CUI [1,2]
C1517001
pre-existing device (e.g., pacing lead) in coronary sinus (cs) / great cardiac vein (gcv)
Description

Device Pre-existing Coronary sinus | Device Pre-existing Great cardiac vein | Leads

Data type

boolean

Alias
UMLS CUI [1,1]
C0025080
UMLS CUI [1,2]
C2347662
UMLS CUI [1,3]
C0456944
UMLS CUI [2,1]
C0025080
UMLS CUI [2,2]
C2347662
UMLS CUI [2,3]
C1280939
UMLS CUI [3]
C0181586
presence of a coronary artery stent under the cs / gcv in the implant target zone
Description

Coronary artery stent Coronary sinus | Coronary artery stent Great cardiac vein | Coronary artery stent Implant Target Zone

Data type

boolean

Alias
UMLS CUI [1,1]
C0687568
UMLS CUI [1,2]
C0456944
UMLS CUI [2,1]
C0687568
UMLS CUI [2,2]
C1280939
UMLS CUI [3,1]
C0687568
UMLS CUI [3,2]
C0021102
UMLS CUI [3,3]
C1521840
UMLS CUI [3,4]
C1710706
presence of left atrial appendage (laa) clot.
Description

Left Atrial Appendage Clot

Data type

boolean

Alias
UMLS CUI [1,1]
C4284918
UMLS CUI [1,2]
C0302148
presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dl
Description

Renal dysfunction Primary | Renal Insufficiency | Creatinine measurement, serum

Data type

boolean

Alias
UMLS CUI [1,1]
C3279454
UMLS CUI [1,2]
C0205225
UMLS CUI [2]
C1565489
UMLS CUI [3]
C0201976
inability to undertake a six-minute walk test due to physical restrictions/limitations
Description

6-Minute Walk Test Unable | Etiology Restriction Physical

Data type

boolean

Alias
UMLS CUI [1,1]
C0430515
UMLS CUI [1,2]
C1299582
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0443288
UMLS CUI [2,3]
C0205485
chronic severe pathology limiting survival to less than 12-months
Description

Chronic disease Severe | Life Expectancy Limited

Data type

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
Back to the top of the page

Similar models

Eligibility Mitral Valve Insufficiency NCT02325830

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Dilated ischemic cardiomyopathy | Non-ischemic dilated cardiomyopathy
Item
diagnosis of dilated ischemic or non-ischemic cardiomyopathy
boolean
C2063324 (UMLS CUI [1])
C1168330 (UMLS CUI [2])
Mitral Valve Insufficiency | Mitral Valve Insufficiency Moderate | Mitral valve regurgitation, moderate to severe | Mitral Valve Insufficiency Severe
Item
functional mitral regurgitation: 2+ (moderate), 3+ (moderate/severe), or 4+ (severe)
boolean
C0026266 (UMLS CUI [1])
C0026266 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
C4478243 (UMLS CUI [3])
C0026266 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
New York Heart Association Classification
Item
new york heart association (nyha) ii, iii, or iv
boolean
C1275491 (UMLS CUI [1])
6-Minute Walk Test Meter
Item
six minute walk distance of at least 150 meters and no farther than 450 meters
boolean
C0430515 (UMLS CUI [1,1])
C0475209 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction ≤ 40 %
boolean
C0428772 (UMLS CUI [1])
Left ventricular end-diastolic dimension | Left ventricular end-diastolic dimension Body Surface Area
Item
lv end diastolic dimension (lvedd) >55mm or lvedd/body surface area (bsa) > 3.0cm/m2
boolean
C1142231 (UMLS CUI [1])
C1142231 (UMLS CUI [2,1])
C0005902 (UMLS CUI [2,2])
Pharmacotherapy Stable Heart failure
Item
stable heart failure medication regimen for at least three (3) months prior to index procedure
boolean
C0013216 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Item Group
C0680251 (UMLS CUI)
Hospitalization Due to Myocardial Infarction | Hospitalization Due to Coronary Artery Bypass Surgery | Hospitalization Due to Unstable Angina
Item
hospitalization in past three (3) months due to myocardial infarction, coronary artery bypass graft surgery, and/or unstable angina
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0010055 (UMLS CUI [2,3])
C0019993 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0002965 (UMLS CUI [3,3])
Hospitalization Due to Coronary angioplasty | Hospitalization Due to Placement of stent
Item
hospitalization in the past 30 days for coronary angioplasty or stent placement
boolean
C0019993 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0190211 (UMLS CUI [1,3])
C0019993 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0522776 (UMLS CUI [2,3])
Cardiac Surgery procedure Expected
Item
subjects expected to require any cardiac surgery within one (1) year
boolean
C0018821 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Percutaneous Coronary Intervention Expected
Item
subjects expected to require any percutaneous coronary intervention within 30 days of enrollment
boolean
C1532338 (UMLS CUI [1,1])
C1517001 (UMLS CUI [1,2])
Device Pre-existing Coronary sinus | Device Pre-existing Great cardiac vein | Leads
Item
pre-existing device (e.g., pacing lead) in coronary sinus (cs) / great cardiac vein (gcv)
boolean
C0025080 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0456944 (UMLS CUI [1,3])
C0025080 (UMLS CUI [2,1])
C2347662 (UMLS CUI [2,2])
C1280939 (UMLS CUI [2,3])
C0181586 (UMLS CUI [3])
Coronary artery stent Coronary sinus | Coronary artery stent Great cardiac vein | Coronary artery stent Implant Target Zone
Item
presence of a coronary artery stent under the cs / gcv in the implant target zone
boolean
C0687568 (UMLS CUI [1,1])
C0456944 (UMLS CUI [1,2])
C0687568 (UMLS CUI [2,1])
C1280939 (UMLS CUI [2,2])
C0687568 (UMLS CUI [3,1])
C0021102 (UMLS CUI [3,2])
C1521840 (UMLS CUI [3,3])
C1710706 (UMLS CUI [3,4])
Left Atrial Appendage Clot
Item
presence of left atrial appendage (laa) clot.
boolean
C4284918 (UMLS CUI [1,1])
C0302148 (UMLS CUI [1,2])
Renal dysfunction Primary | Renal Insufficiency | Creatinine measurement, serum
Item
presence of primary renal dysfunction or significantly compromised renal function as reflected by a serum creatinine > 2.2 mg/dl
boolean
C3279454 (UMLS CUI [1,1])
C0205225 (UMLS CUI [1,2])
C1565489 (UMLS CUI [2])
C0201976 (UMLS CUI [3])
6-Minute Walk Test Unable | Etiology Restriction Physical
Item
inability to undertake a six-minute walk test due to physical restrictions/limitations
boolean
C0430515 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0015127 (UMLS CUI [2,1])
C0443288 (UMLS CUI [2,2])
C0205485 (UMLS CUI [2,3])
Chronic disease Severe | Life Expectancy Limited
Item
chronic severe pathology limiting survival to less than 12-months
boolean
C0008679 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0023671 (UMLS CUI [2,1])
C0439801 (UMLS CUI [2,2])
Back to the top of the page 

Contact

Please use this form for feedback, questions and suggestions for improvements.

Fields marked with * are required.

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