ID

36410

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT02325830

Stichworte

Versionen (1)
  1. 12.05.19 12.05.19 -
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See clinicaltrials.gov

Hochgeladen am

12. Mai 2019

DOI

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Eligibility Mitral Valve Insufficiency NCT02325830

Englisch

Eligibility Mitral Valve Insufficiency NCT02325830

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Dilated ischemic cardiomyopathy | Non-ischemic dilated cardiomyopathy

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

New York Heart Association Classification

Datentyp

boolean

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

6-Minute Walk Test Meter

Datentyp

boolean

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

Left ventricular ejection fraction

Datentyp

boolean

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

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

Datentyp

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
Beschreibung

Pharmacotherapy Stable Heart failure

Datentyp

boolean

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

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Cardiac Surgery procedure Expected

Datentyp

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
Beschreibung

Percutaneous Coronary Intervention Expected

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.
Beschreibung

Left Atrial Appendage Clot

Datentyp

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
Beschreibung

Renal dysfunction Primary | Renal Insufficiency | Creatinine measurement, serum

Datentyp

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
Beschreibung

6-Minute Walk Test Unable | Etiology Restriction Physical

Datentyp

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
Beschreibung

Chronic disease Severe | Life Expectancy Limited

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0008679
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0023671
UMLS CUI [2,2]
C0439801
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Ähnliche Modelle

Eligibility Mitral Valve Insufficiency NCT02325830

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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])
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