Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363

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StudyEvent: Eligibility
1. Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de datos

Alias

Inclusion Criteria

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])

Exclusion Criteria

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])

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Eligibility Advanced Refractory Left Ventricular Heart Failure NCT02170363