Indication Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Indication Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Item
must be indicated for a guidant crt-p or crt-d device
boolean
C3146298 (UMLS CUI [1,1])
C1737639 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1736558 (UMLS CUI [2,2])
Creatinine measurement, serum
Item
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment
boolean
C0201976 (UMLS CUI [1])
Age
Item
age 18 or above, or of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
Informed Consent | Device implant Willing | Protocol Compliance
Item
willing and capable of providing informed consent, undergoing a device implant, participating in all testing associated with this clinical investigation at an approved clinical investigation center and at the intervals defined by this protocol
boolean
C0021430 (UMLS CUI [1])
C0948629 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Resident Stable geographical | Follow-up Resident Available
Item
geographically stable residents who are available for follow-up
boolean
C2347958 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0681784 (UMLS CUI [1,3])
C3274571 (UMLS CUI [2,1])
C2347958 (UMLS CUI [2,2])
C0470187 (UMLS CUI [2,3])
Hypersensitivity Dexamethasone acetate Dose
Item
have a known hypersensitivity to a 0.5 mg nominal dose of dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Cardiac Resynchronization Therapy | Coronary venous pacing lead | Lead Placement Left ventricular Attempted
Item
have or had previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
C2346652 (UMLS CUI [3,1])
C0225897 (UMLS CUI [3,2])
C1516084 (UMLS CUI [3,3])
Electric Countershock Leads Pre-existing | Pacing Leads Right ventricular
Item
have pre-existing cardioversion/defibrillation leads or right ventricular pacing leads other than those specified in the investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads)
boolean
C0013778 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C1285520 (UMLS CUI [2,1])
C0181586 (UMLS CUI [2,2])
C0225883 (UMLS CUI [2,3])
Dialysis Patient need for
Item
currently requiring dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Myocardial Infarction | Angina, Unstable | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery
Item
have had a myocardial infarct, unstable angina, percutaneous coronary intervention, or coronary artery bypass graft during the preceding 30 days prior to enrollment
boolean
C0027051 (UMLS CUI [1])
C0002965 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
Hypertrophic Cardiomyopathy | Restrictive cardiomyopathy secondary to infiltrations | Amyloidosis | Sarcoidosis
Item
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
boolean
C0007194 (UMLS CUI [1])
C0264839 (UMLS CUI [2])
C0002726 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
Life Expectancy | Heart Transplantation Expected
Item
documented life expectancy of less than six months or expected to undergo heart transplant within the next six months
boolean
C0023671 (UMLS CUI [1])
C0018823 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results | Investigational New Drugs
Item
enrolled or participating in any concurrent study, including drug investigations, without guidant written approval, that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
C0013230 (UMLS CUI [2])
Artificial cardiac pacemaker Unipolar Pre-existing | Explantation Missing
Item
have a pre-existing unipolar pacemaker that will not be explanted/abandoned
boolean
C0030163 (UMLS CUI [1,1])
C0443340 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0561946 (UMLS CUI [2,1])
C1705492 (UMLS CUI [2,2])
heart - tricuspid valve
Item
have a mechanical tricuspid heart valve
boolean
C0869757 (UMLS CUI [1])
Pregnancy | Pregnancy, Planned | Childbearing Potential Pregnancy test negative
Item
women who are pregnant or plan to become pregnant. note: women of childbearing potential must have a negative pregnancy test within seven days of enrollment.
boolean
C0032961 (UMLS CUI [1])
C0032992 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0427780 (UMLS CUI [3,2])