ID

14820

Beschreibung

Thoratec Corporation HeartMate III™ CE Mark Clinical Investigation Plan; ODM derived from: https://clinicaltrials.gov/show/NCT02170363

Link

https://clinicaltrials.gov/show/NCT02170363

Stichworte

Versionen (1)
  1. 29.04.16 29.04.16 -
Hochgeladen am

29. April 2016

DOI

Für eine Beantragung loggen Sie sich ein.

Lizenz

Creative Commons BY 4.0
Modell Kommentare :

Hier können Sie das Modell kommentieren. Über die Sprechblasen an den Itemgruppen und Items können Sie diese spezifisch kommentieren.

Zurück zu Modell Kommentaren
Itemgroup Kommentare für :

Item Kommentare für :

Um Formulare herunterzuladen müssen Sie angemeldet sein. Bitte loggen Sie sich ein oder registrieren Sie sich kostenlos.

Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363

Englisch

Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
patient or legal representative has signed informed consent form (icf)
Beschreibung

informed consent

Datentyp

boolean

Alias
UMLS CUI [1]
C0021430
age ≥ 18 years
Beschreibung

age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
bsa ≥ 1.2 m2
Beschreibung

bsa

Datentyp

boolean

Alias
UMLS CUI [1]
C0005902
nyha iiib or iv or acc/aha stage d
Beschreibung

nyha

Datentyp

boolean

Alias
UMLS CUI [1]
C1275491
lvef ≤ 25%
Beschreibung

lvef ≤ 25%

Datentyp

boolean

Alias
UMLS CUI [1]
C0428772
ci ≤ 2.2 l/min/m2, while not on inotropes
Beschreibung

Cardiac index (CI)

Datentyp

boolean

Alias
UMLS CUI [1]
C0428776
on optimal medical management (omm), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond,
Beschreibung

optimal medical management

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1444286
UMLS CUI [1,2]
C0162791
in nyha class iiib or iv heart failure for at least 14 days and dependent on intraaortic balloon pump (iabp) for at least 7 days,
Beschreibung

intraaortic balloon pump (iabp)

Datentyp

boolean

Alias
UMLS CUI [1]
C0702122
inotrope dependent/unable to wean from inotropes
Beschreibung

inotrope dependent

Datentyp

boolean

Alias
UMLS CUI [1]
C0007209
listed for transplant
Beschreibung

listed for transplant

Datentyp

boolean

females of child bearing age must agree to use adequate contraception
Beschreibung

contraception

Datentyp

boolean

Alias
UMLS CUI [1]
C0700589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
etiology of hf due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
Beschreibung

etiology of hf

Datentyp

boolean

Alias
UMLS CUI [1]
C0018801
technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
Beschreibung

high surgical risk

Datentyp

boolean

Alias
UMLS CUI [1]
C1531717
existence of ongoing mechanical circulatory support (mcs) other than iabp
Beschreibung

mechanical circulatory support

Datentyp

boolean

Alias
UMLS CUI [1]
C3274791
positive pregnancy test if of childbearing potential
Beschreibung

positive pregnancy test

Datentyp

boolean

Alias
UMLS CUI [1]
C0240802
lactating mothers
Beschreibung

lactating

Datentyp

boolean

Alias
UMLS CUI [1]
C0006147
presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of lvad implant
Beschreibung

mechanical aortic cardiac valve

Datentyp

boolean

Alias
UMLS CUI [1]
C2825203
history of any organ transplant
Beschreibung

history of any organ transplant

Datentyp

boolean

Alias
UMLS CUI [1]
C0455639
platelet count < 100,000 x 103/l (< 100,000/ml)
Beschreibung

platelet count

Datentyp

boolean

Alias
UMLS CUI [1]
C0005821
psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and lvas management
Beschreibung

psychiatric disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0004936
history of confirmed, untreated aaa > 5 cm in diameter
Beschreibung

Aortic Aneurysm

Datentyp

boolean

Alias
UMLS CUI [1]
C0003486
presence of an active, uncontrolled infection
Beschreibung

infection

Datentyp

boolean

Alias
UMLS CUI [1]
C0009450
intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients'
Beschreibung

anticoagulant or antiplatelet therapies

Datentyp

boolean

Alias
UMLS CUI [1]
C0003280
UMLS CUI [2]
C1096021
health status
Beschreibung

health status

Datentyp

boolean

Alias
UMLS CUI [1]
C0018759
presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
Beschreibung

severe end organ dysfunction

Datentyp

boolean

Alias
UMLS CUI [1]
C0342953
an inr ≥ 2.5 not due to anticoagulation therapy
Beschreibung

inr

Datentyp

boolean

Alias
UMLS CUI [1]
C0525032
total bilirubin > 43 umol/l (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
Beschreibung

total bilirubin

Datentyp

boolean

Alias
UMLS CUI [1]
C0201913
history of severe chronic obstructive pulmonary disease (copd) defined by fev1/fvc < 0.7, or fev1 <50% predicted
Beschreibung

Chronic Obstructive Airway Disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0024117
fixed pulmonary hypertension with a most recent pvr ≥ 8 wood units that is unresponsive to pharmacologic intervention
Beschreibung

pulmonary hypertension

Datentyp

boolean

Alias
UMLS CUI [1]
C0020542
history of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
Beschreibung

history of stroke

Datentyp

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007820
serum creatinine ≥221umol/l (2.5 mg/dl) or the need for chronic renal replacement therapy
Beschreibung

serum creatinine

Datentyp

boolean

Alias
UMLS CUI [1]
C0201976
significant peripheral vascular disease (pvd) accompanied by rest pain or extremity ulceration
Beschreibung

peripheral vascular disease

Datentyp

boolean

Alias
UMLS CUI [1]
C0085096
patient has moderate to severe aortic insufficiency without plans for correction during pump implant
Beschreibung

aortic insufficiency

Datentyp

boolean

Alias
UMLS CUI [1]
C0003504
pre albumin < 150 mg/l, or albumin < 30g/l (3 g/dl)
Beschreibung

albumin < 30g/l (3 g/dl)

Datentyp

boolean

Alias
UMLS CUI [1]
C0201838
planned bi-vad support prior to enrollment
Beschreibung

bi-vad

Datentyp

boolean

Alias
UMLS CUI [1]
C0085842
patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
Beschreibung

hypo-, hyper-coagulable state

Datentyp

boolean

Alias
UMLS CUI [1]
C2873803
UMLS CUI [2]
C2873803
participation in any other clinical investigation that is likely to confound study results or affect the study
Beschreibung

participation in any other clinical investigation

Datentyp

boolean

Alias
UMLS CUI [1]
C2348568
any condition other than hf that could limit survival to less than 24 months
Beschreibung

life expectancy

Datentyp

boolean

Alias
UMLS CUI [1]
C0023671
Zum Seitenanfang zurückkehren

Ähnliche Modelle

Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
informed consent
Item
patient or legal representative has signed informed consent form (icf)
boolean
C0021430 (UMLS CUI [1])
age
Item
age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
bsa
Item
bsa ≥ 1.2 m2
boolean
C0005902 (UMLS CUI [1])
nyha
Item
nyha iiib or iv or acc/aha stage d
boolean
C1275491 (UMLS CUI [1])
lvef ≤ 25%
Item
lvef ≤ 25%
boolean
C0428772 (UMLS CUI [1])
Cardiac index (CI)
Item
ci ≤ 2.2 l/min/m2, while not on inotropes
boolean
C0428776 (UMLS CUI [1])
optimal medical management
Item
on optimal medical management (omm), based on current heart failure practice guidelines for at least 45 out of the last 60 days and are failing to respond,
boolean
C1444286 (UMLS CUI [1,1])
C0162791 (UMLS CUI [1,2])
intraaortic balloon pump (iabp)
Item
in nyha class iiib or iv heart failure for at least 14 days and dependent on intraaortic balloon pump (iabp) for at least 7 days,
boolean
C0702122 (UMLS CUI [1])
inotrope dependent
Item
inotrope dependent/unable to wean from inotropes
boolean
C0007209 (UMLS CUI [1])
listed for transplant
Item
listed for transplant
boolean
contraception
Item
females of child bearing age must agree to use adequate contraception
boolean
C0700589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
etiology of hf
Item
etiology of hf due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
boolean
C0018801 (UMLS CUI [1])
high surgical risk
Item
technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
boolean
C1531717 (UMLS CUI [1])
mechanical circulatory support
Item
existence of ongoing mechanical circulatory support (mcs) other than iabp
boolean
C3274791 (UMLS CUI [1])
positive pregnancy test
Item
positive pregnancy test if of childbearing potential
boolean
C0240802 (UMLS CUI [1])
lactating
Item
lactating mothers
boolean
C0006147 (UMLS CUI [1])
mechanical aortic cardiac valve
Item
presence of mechanical aortic cardiac valve that will not be converted to a bioprosthesis at the time of lvad implant
boolean
C2825203 (UMLS CUI [1])
history of any organ transplant
Item
history of any organ transplant
boolean
C0455639 (UMLS CUI [1])
platelet count
Item
platelet count < 100,000 x 103/l (< 100,000/ml)
boolean
C0005821 (UMLS CUI [1])
psychiatric disease
Item
psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and lvas management
boolean
C0004936 (UMLS CUI [1])
Aortic Aneurysm
Item
history of confirmed, untreated aaa > 5 cm in diameter
boolean
C0003486 (UMLS CUI [1])
infection
Item
presence of an active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1])
anticoagulant or antiplatelet therapies
Item
intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy the investigator will require based upon the patients'
boolean
C0003280 (UMLS CUI [1])
C1096021 (UMLS CUI [2])
health status
Item
health status
boolean
C0018759 (UMLS CUI [1])
severe end organ dysfunction
Item
presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
boolean
C0342953 (UMLS CUI [1])
inr
Item
an inr ≥ 2.5 not due to anticoagulation therapy
boolean
C0525032 (UMLS CUI [1])
total bilirubin
Item
total bilirubin > 43 umol/l (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
boolean
C0201913 (UMLS CUI [1])
Chronic Obstructive Airway Disease
Item
history of severe chronic obstructive pulmonary disease (copd) defined by fev1/fvc < 0.7, or fev1 <50% predicted
boolean
C0024117 (UMLS CUI [1])
pulmonary hypertension
Item
fixed pulmonary hypertension with a most recent pvr ≥ 8 wood units that is unresponsive to pharmacologic intervention
boolean
C0020542 (UMLS CUI [1])
history of stroke
Item
history of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
boolean
C0038454 (UMLS CUI [1])
C0007820 (UMLS CUI [2])
serum creatinine
Item
serum creatinine ≥221umol/l (2.5 mg/dl) or the need for chronic renal replacement therapy
boolean
C0201976 (UMLS CUI [1])
peripheral vascular disease
Item
significant peripheral vascular disease (pvd) accompanied by rest pain or extremity ulceration
boolean
C0085096 (UMLS CUI [1])
aortic insufficiency
Item
patient has moderate to severe aortic insufficiency without plans for correction during pump implant
boolean
C0003504 (UMLS CUI [1])
albumin < 30g/l (3 g/dl)
Item
pre albumin < 150 mg/l, or albumin < 30g/l (3 g/dl)
boolean
C0201838 (UMLS CUI [1])
bi-vad
Item
planned bi-vad support prior to enrollment
boolean
C0085842 (UMLS CUI [1])
hypo-, hyper-coagulable state
Item
patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
boolean
C2873803 (UMLS CUI [1])
C2873803 (UMLS CUI [2])
participation in any other clinical investigation
Item
participation in any other clinical investigation that is likely to confound study results or affect the study
boolean
C2348568 (UMLS CUI [1])
life expectancy
Item
any condition other than hf that could limit survival to less than 24 months
boolean
C0023671 (UMLS CUI [1])
Zum Seitenanfang zurückkehren 

Kontakt

Benutzen Sie dieses Formular für Rückmeldungen, Fragen und Verbesserungsvorschläge.

Mit * gekennzeichnete Felder sind notwendig.

Hilfe

Benötigen Sie Hilfe bei der Suche? Um mehr Details zu erfahren und die Suche effektiver nutzen zu können schauen Sie sich doch das entsprechende Video auf unserer Tutorial Seite an.

Zum Video