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])
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])