ID

35960

Descrição

HeartMate 3™ LIS Study; ODM derived from: https://clinicaltrials.gov/show/NCT02475460

Link

https://clinicaltrials.gov/show/NCT02475460

Palavras-chave

Versões (1)
  1. 06/04/2019 06/04/2019 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

6 de abril de 2019

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Heart Failure NCT02475460

Inglês

Eligibility Heart Failure NCT02475460

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Informed Consent | Informed Consent Patient Representatives

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
2. age ≥ 18 years
Descrição

Age

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0001779
3. bsa ≥ 1.2 m2
Descrição

Body Surface Area

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0005902
4. nyha iiib or iv, or acc/aha stage d
Descrição

Heart failure New York Heart Association Classification | Heart failure Stage

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1306673
5. lvef ≤ 25%
Descrição

Left ventricular ejection fraction

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428772
6. ci ≤ 2.2 l/min/m2, while not on inotropes (if patient is treated with inotropes at baseline, this does not apply)
Descrição

Cardiac index | Inotropic agent Absent

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0428776
UMLS CUI [2,1]
C0304509
UMLS CUI [2,2]
C0332197
7. patients must also meet one of the following:
Descrição

Criteria Fulfill

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
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, or
Descrição

Disease Management Optimal Heart failure | Response failed

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0376636
UMLS CUI [1,2]
C2698651
UMLS CUI [1,3]
C0018801
UMLS CUI [2,1]
C1704632
UMLS CUI [2,2]
C0231175
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, or
Descrição

Heart failure New York Heart Association Classification | Dependence on Intra-aortic balloon pump

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0439857
UMLS CUI [2,2]
C0702122
inotrope dependent/unable to wean from inotropes or
Descrição

Dependence on Inotropic agent

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0439857
UMLS CUI [1,2]
C0304509
listed for transplant
Descrição

Patient on waiting list Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0422768
UMLS CUI [1,2]
C0040732
8. females of child bearing age must agree to use adequate contraception-
Descrição

Childbearing Potential Contraceptive methods

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0700589
Exclusion Criteria
Descrição

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. etiology of heart failure (hf) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
Descrição

Heart failure | Etiology Thyroid Disease uncorrected | Etiology Cardiomyopathy Obstructive | Etiology Disorder of pericardium | Etiology Amyloidosis | Etiology Restrictive cardiomyopathy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0018801
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C0040128
UMLS CUI [2,3]
C4072785
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0878544
UMLS CUI [3,3]
C0549186
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C0265122
UMLS CUI [5,1]
C0015127
UMLS CUI [5,2]
C0002726
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C0007196
2. technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
Descrição

Technical Problem | High risk Surgical

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1710348
UMLS CUI [2,1]
C4319571
UMLS CUI [2,2]
C0543467
3. existence of ongoing mechanical circulatory support (mcs) other than iabp
Descrição

Mechanical Circulatory Support | Exception Intra-aortic balloon pump

Tipo de dados

boolean

Alias
UMLS CUI [1]
C3274791
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0702122
4. positive pregnancy test if of childbearing potential
Descrição

Pregnancy test positive

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0240802
5. lactating mothers
Descrição

Breast Feeding

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0006147
6. presence of mechanical aortic cardiac valve
Descrição

Aortic valve prosthesis

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0182431
7. history of any organ transplant
Descrição

Organ Transplantation

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0029216
8. platelet count < 100,000 x 103/l (< 100,000/ml)
Descrição

Platelet Count measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0032181
9. psychiatric disease/disorder, irreversible cognitive dysfunction or psychosocial issues that are likely to impair compliance with the study protocol and lvas management
Descrição

Mental disorders Impairing Protocol Compliance | Cognitive dysfunction Impairing Protocol Compliance | Psychosocial problem Impairing Protocol Compliance

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0004936
UMLS CUI [1,2]
C0221099
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0338656
UMLS CUI [2,2]
C0221099
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0740697
UMLS CUI [3,2]
C0221099
UMLS CUI [3,3]
C0525058
10. history of confirmed, untreated aaa > 5 cm in diameter
Descrição

Abdominal Aortic Aneurysm Diameter

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0162871
UMLS CUI [1,2]
C1301886
11. presence of an active, uncontrolled infection
Descrição

Communicable Disease Uncontrolled

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
12. intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status
Descrição

Intolerance Anticoagulant therapy | Intolerance Antiplatelet therapy | Intolerance Perioperative Care | Intolerance Postoperative Care

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0231199
UMLS CUI [1,2]
C0150457
UMLS CUI [2,1]
C0231199
UMLS CUI [2,2]
C1096021
UMLS CUI [3,1]
C0231199
UMLS CUI [3,2]
C0150706
UMLS CUI [4,1]
C0231199
UMLS CUI [4,2]
C0032786
13. presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
Descrição

Risk factors | Indication Organ dysfunction Severe

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0035648
UMLS CUI [2,1]
C3146298
UMLS CUI [2,2]
C0349410
UMLS CUI [2,3]
C0205082
an inr ≥ 2.5 not due to anticoagulation therapy
Descrição

INR raised Independent of Anticoagulation Therapy

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0853225
UMLS CUI [1,2]
C0332291
UMLS CUI [1,3]
C0003281
total bilirubin > 43 umol/l (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
Descrição

Serum total bilirubin measurement | SHOCK LIVER | Liver Cirrhosis Biopsy

Tipo de dados

boolean

Alias
UMLS CUI [1]
C1278039
UMLS CUI [2]
C0745746
UMLS CUI [3,1]
C0023890
UMLS CUI [3,2]
C0193388
history of severe chronic obstructive pulmonary disease (copd) defined by fev1/fvc < 0.7, or fev1 <50% predicted
Descrição

Severe chronic obstructive pulmonary disease | FEV1 to FVC Ratio Measurement | Percent predicted FEV1

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C3815113
UMLS CUI [3]
C0730561
| Severe chronic obstructive pulmonary disease | C3815113 Forced Expiratory Volume in 1 Second to Forced Vital Capacity Ratio Measurement | C0730561 Percent predicted FEV1
NA
fixed pulmonary hypertension with a most recent pvr ≥ 8 wood units that is unresponsive to pharmacologic intervention
Descrição

Pulmonary Hypertension Stable | Unresponsive to Pharmacotherapy | Pulmonary Vascular Resistance Wood units

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0020542
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0205269
UMLS CUI [2,2]
C0013216
UMLS CUI [3,1]
C0456261
UMLS CUI [3,2]
C0439525
history of stroke within 90 days prior to enrollment, or a history of cerebrovascular disease with significant (> 80%) carotid artery stenosis
Descrição

Cerebrovascular accident | Cerebrovascular Disorder | Carotid Stenosis Percentage

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0007820
UMLS CUI [3,1]
C0007282
UMLS CUI [3,2]
C0439165
serum creatinine ≥ 221umol/l (2.5 mg/dl) or the need for chronic renal replacement therapy
Descrição

Creatinine measurement, serum | Patient need for Renal Replacement Therapy chronic

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2,1]
C0686904
UMLS CUI [2,2]
C0206074
UMLS CUI [2,3]
C0205191
significant peripheral vascular disease (pvd) accompanied by rest pain or extremity ulceration
Descrição

Peripheral Vascular Disease Associated with Rest pain | Peripheral Vascular Disease Associated with Extremity Ulceration

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0332281
UMLS CUI [1,3]
C0234253
UMLS CUI [2,1]
C0085096
UMLS CUI [2,2]
C0332281
UMLS CUI [2,3]
C0015385
UMLS CUI [2,4]
C3887532
14. aortic valve regurgitation > grade 1
Descrição

Aortic Valve Insufficiency Grade

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0003504
UMLS CUI [1,2]
C0441800
15. pre albumin < 150 mg/l, or albumin < 30g/l (3 g/dl)
Descrição

Prealbumin measurement | Albumin measurement

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0337441
UMLS CUI [2]
C0201838
16. planned bi-vad support prior to enrollment
Descrição

Implantation of biventricular assist device Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0397131
UMLS CUI [1,2]
C1301732
17. patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
Descrição

Hypocoagulable state | Thrombophilia | Disseminated Intravascular Coagulation | Heparin-induced thrombocytopenia

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0235601
UMLS CUI [2]
C0398623
UMLS CUI [3]
C0012739
UMLS CUI [4]
C0272285
18. planned concomitant intra-cardiac cardiac surgery
Descrição

Cardiac Surgery procedure Planned

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
19. thrombus formation in the atrium or left ventricle identified by echocardiogram
Descrição

Thrombus Formation Atrium Echocardiography | Echocardiography: thrombus formation of left ventricle

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0087086
UMLS CUI [1,2]
C1522492
UMLS CUI [1,3]
C0018792
UMLS CUI [1,4]
C0013516
UMLS CUI [2]
C2021231
20. previous sternotomy or left-sided thoracotomy
Descrição

Sternotomy | Thoracotomy Left sided

Tipo de dados

boolean

Alias
UMLS CUI [1]
C0185792
UMLS CUI [2,1]
C0039991
UMLS CUI [2,2]
C0443246
21. participation in any other clinical investigation that is likely to confound study results or affect the study
Descrição

Study Subject Participation Status Interferes with Research results | Study Subject Participation Status Affecting Clinical Trial

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0683954
UMLS CUI [2,1]
C2348568
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0008976
22. any condition other than hf that could limit survival to less than 6 months
Descrição

Condition Limiting Survival

Tipo de dados

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C0439801
UMLS CUI [1,3]
C0038952
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Eligibility Heart Failure NCT02475460

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
Alias
Item Group
C1512693 (UMLS CUI)
Informed Consent | Informed Consent Patient Representatives
Item
1. patient or legal representative has signed informed consent form (icf)
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Age
Item
2. age ≥ 18 years
boolean
C0001779 (UMLS CUI [1])
Body Surface Area
Item
3. bsa ≥ 1.2 m2
boolean
C0005902 (UMLS CUI [1])
Heart failure New York Heart Association Classification | Heart failure Stage
Item
4. nyha iiib or iv, or acc/aha stage d
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1306673 (UMLS CUI [2,2])
Left ventricular ejection fraction
Item
5. lvef ≤ 25%
boolean
C0428772 (UMLS CUI [1])
Cardiac index | Inotropic agent Absent
Item
6. ci ≤ 2.2 l/min/m2, while not on inotropes (if patient is treated with inotropes at baseline, this does not apply)
boolean
C0428776 (UMLS CUI [1])
C0304509 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Criteria Fulfill
Item
7. patients must also meet one of the following:
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Disease Management Optimal Heart failure | Response failed
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, or
boolean
C0376636 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C1704632 (UMLS CUI [2,1])
C0231175 (UMLS CUI [2,2])
Heart failure New York Heart Association Classification | Dependence on Intra-aortic balloon pump
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, or
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0439857 (UMLS CUI [2,1])
C0702122 (UMLS CUI [2,2])
Dependence on Inotropic agent
Item
inotrope dependent/unable to wean from inotropes or
boolean
C0439857 (UMLS CUI [1,1])
C0304509 (UMLS CUI [1,2])
Patient on waiting list Transplantation
Item
listed for transplant
boolean
C0422768 (UMLS CUI [1,1])
C0040732 (UMLS CUI [1,2])
Childbearing Potential Contraceptive methods
Item
8. females of child bearing age must agree to use adequate contraception-
boolean
C3831118 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Heart failure | Etiology Thyroid Disease uncorrected | Etiology Cardiomyopathy Obstructive | Etiology Disorder of pericardium | Etiology Amyloidosis | Etiology Restrictive cardiomyopathy
Item
1. etiology of heart failure (hf) due to or associated with uncorrected thyroid disease, obstructive cardiomyopathy, pericardial disease, amyloidosis or restrictive cardiomyopathy
boolean
C0018801 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0040128 (UMLS CUI [2,2])
C4072785 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0878544 (UMLS CUI [3,2])
C0549186 (UMLS CUI [3,3])
C0015127 (UMLS CUI [4,1])
C0265122 (UMLS CUI [4,2])
C0015127 (UMLS CUI [5,1])
C0002726 (UMLS CUI [5,2])
C0015127 (UMLS CUI [6,1])
C0007196 (UMLS CUI [6,2])
Technical Problem | High risk Surgical
Item
2. technical obstacles which pose an inordinately high surgical risk, in the judgment of the investigator
boolean
C1710348 (UMLS CUI [1])
C4319571 (UMLS CUI [2,1])
C0543467 (UMLS CUI [2,2])
Mechanical Circulatory Support | Exception Intra-aortic balloon pump
Item
3. existence of ongoing mechanical circulatory support (mcs) other than iabp
boolean
C3274791 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0702122 (UMLS CUI [2,2])
Pregnancy test positive
Item
4. positive pregnancy test if of childbearing potential
boolean
C0240802 (UMLS CUI [1])
Breast Feeding
Item
5. lactating mothers
boolean
C0006147 (UMLS CUI [1])
Aortic valve prosthesis
Item
6. presence of mechanical aortic cardiac valve
boolean
C0182431 (UMLS CUI [1])
Organ Transplantation
Item
7. history of any organ transplant
boolean
C0029216 (UMLS CUI [1])
Platelet Count measurement
Item
8. platelet count < 100,000 x 103/l (< 100,000/ml)
boolean
C0032181 (UMLS CUI [1])
Mental disorders Impairing Protocol Compliance | Cognitive dysfunction Impairing Protocol Compliance | Psychosocial problem Impairing Protocol Compliance
Item
9. 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 [1,1])
C0221099 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0338656 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0740697 (UMLS CUI [3,1])
C0221099 (UMLS CUI [3,2])
C0525058 (UMLS CUI [3,3])
Abdominal Aortic Aneurysm Diameter
Item
10. history of confirmed, untreated aaa > 5 cm in diameter
boolean
C0162871 (UMLS CUI [1,1])
C1301886 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
11. presence of an active, uncontrolled infection
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Intolerance Anticoagulant therapy | Intolerance Antiplatelet therapy | Intolerance Perioperative Care | Intolerance Postoperative Care
Item
12. intolerance to anticoagulant or antiplatelet therapies or any other peri/post-operative therapy that the investigator will require based upon the patients' health status
boolean
C0231199 (UMLS CUI [1,1])
C0150457 (UMLS CUI [1,2])
C0231199 (UMLS CUI [2,1])
C1096021 (UMLS CUI [2,2])
C0231199 (UMLS CUI [3,1])
C0150706 (UMLS CUI [3,2])
C0231199 (UMLS CUI [4,1])
C0032786 (UMLS CUI [4,2])
Risk factors | Indication Organ dysfunction Severe
Item
13. presence of any one of the following risk factors for indications of severe end organ dysfunction or failure:
boolean
C0035648 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C0349410 (UMLS CUI [2,2])
C0205082 (UMLS CUI [2,3])
INR raised Independent of Anticoagulation Therapy
Item
an inr ≥ 2.5 not due to anticoagulation therapy
boolean
C0853225 (UMLS CUI [1,1])
C0332291 (UMLS CUI [1,2])
C0003281 (UMLS CUI [1,3])
Serum total bilirubin measurement | SHOCK LIVER | Liver Cirrhosis Biopsy
Item
total bilirubin > 43 umol/l (2.5 mg/dl), shock liver, or biopsy proven liver cirrhosis
boolean
C1278039 (UMLS CUI [1])
C0745746 (UMLS CUI [2])
C0023890 (UMLS CUI [3,1])
C0193388 (UMLS CUI [3,2])
Severe chronic obstructive pulmonary disease | FEV1 to FVC Ratio Measurement | Percent predicted FEV1
Item
history of severe chronic obstructive pulmonary disease (copd) defined by fev1/fvc < 0.7, or fev1 <50% predicted
boolean
C0730607 (UMLS CUI [1])
C3815113 (UMLS CUI [2])
C0730561 (UMLS CUI [3])
NA (| Severe chronic obstructive pulmonary disease | C3815113 Forced Expiratory Volume in 1 Second to Forced Vital Capacity Ratio Measurement | C0730561 Percent predicted FEV1)
Pulmonary Hypertension Stable | Unresponsive to Pharmacotherapy | Pulmonary Vascular Resistance Wood units
Item
fixed pulmonary hypertension with a most recent pvr ≥ 8 wood units that is unresponsive to pharmacologic intervention
boolean
C0020542 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0205269 (UMLS CUI [2,1])
C0013216 (UMLS CUI [2,2])
C0456261 (UMLS CUI [3,1])
C0439525 (UMLS CUI [3,2])
Cerebrovascular accident | Cerebrovascular Disorder | Carotid Stenosis Percentage
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])
C0007282 (UMLS CUI [3,1])
C0439165 (UMLS CUI [3,2])
Creatinine measurement, serum | Patient need for Renal Replacement Therapy chronic
Item
serum creatinine ≥ 221umol/l (2.5 mg/dl) or the need for chronic renal replacement therapy
boolean
C0201976 (UMLS CUI [1])
C0686904 (UMLS CUI [2,1])
C0206074 (UMLS CUI [2,2])
C0205191 (UMLS CUI [2,3])
Peripheral Vascular Disease Associated with Rest pain | Peripheral Vascular Disease Associated with Extremity Ulceration
Item
significant peripheral vascular disease (pvd) accompanied by rest pain or extremity ulceration
boolean
C0085096 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0234253 (UMLS CUI [1,3])
C0085096 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0015385 (UMLS CUI [2,3])
C3887532 (UMLS CUI [2,4])
Aortic Valve Insufficiency Grade
Item
14. aortic valve regurgitation > grade 1
boolean
C0003504 (UMLS CUI [1,1])
C0441800 (UMLS CUI [1,2])
Prealbumin measurement | Albumin measurement
Item
15. pre albumin < 150 mg/l, or albumin < 30g/l (3 g/dl)
boolean
C0337441 (UMLS CUI [1])
C0201838 (UMLS CUI [2])
Implantation of biventricular assist device Planned
Item
16. planned bi-vad support prior to enrollment
boolean
C0397131 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Hypocoagulable state | Thrombophilia | Disseminated Intravascular Coagulation | Heparin-induced thrombocytopenia
Item
17. patient has known hypo or hyper coagulable states such as disseminated intravascular coagulation and heparin induced thrombocytopenia
boolean
C0235601 (UMLS CUI [1])
C0398623 (UMLS CUI [2])
C0012739 (UMLS CUI [3])
C0272285 (UMLS CUI [4])
Cardiac Surgery procedure Planned
Item
18. planned concomitant intra-cardiac cardiac surgery
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Thrombus Formation Atrium Echocardiography | Echocardiography: thrombus formation of left ventricle
Item
19. thrombus formation in the atrium or left ventricle identified by echocardiogram
boolean
C0087086 (UMLS CUI [1,1])
C1522492 (UMLS CUI [1,2])
C0018792 (UMLS CUI [1,3])
C0013516 (UMLS CUI [1,4])
C2021231 (UMLS CUI [2])
Sternotomy | Thoracotomy Left sided
Item
20. previous sternotomy or left-sided thoracotomy
boolean
C0185792 (UMLS CUI [1])
C0039991 (UMLS CUI [2,1])
C0443246 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results | Study Subject Participation Status Affecting Clinical Trial
Item
21. participation in any other clinical investigation that is likely to confound study results or affect the study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C2348568 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0008976 (UMLS CUI [2,3])
Condition Limiting Survival
Item
22. any condition other than hf that could limit survival to less than 6 months
boolean
C0348080 (UMLS CUI [1,1])
C0439801 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
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