Heart failure Moderate Symptomatic | Heart failure Severe Symptomatic | New York Heart Association Classification | Ventricular Dysfunction, Left | Cardiac ejection fraction | QRS complex duration | Heart failure Pharmacotherapy Stable Optimal
Item
moderate to severe heart failure (nyha class iii/iv) including left ventricular dysfunction (ef <= 35%) and qrs duration >= 120 ms remaining symptomatic despite stable, optimal heart failure drug therapy.
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0231220 (UMLS CUI [2,3])
C1275491 (UMLS CUI [3])
C0242698 (UMLS CUI [4])
C0232174 (UMLS CUI [5])
C0429025 (UMLS CUI [6])
C0018801 (UMLS CUI [7,1])
C0013216 (UMLS CUI [7,2])
C0205360 (UMLS CUI [7,3])
C2698651 (UMLS CUI [7,4])
Creatinine measurement, serum
Item
creatinine < 2.5 mg/dl obtained no more than two weeks prior to enrollment.
boolean
C0201976 (UMLS CUI [1])
Age | Informed Consent Age Legal
Item
age 18 or above, or of legal age to give informed consent specific to state and national law.
boolean
C0001779 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0001779 (UMLS CUI [2,2])
C1301860 (UMLS CUI [2,3])
Informed Consent | Device implant Capability | 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 investigational center and at the intervals defined by this protocol.
boolean
C0021430 (UMLS CUI [1])
C0948629 (UMLS CUI [2,1])
C2698977 (UMLS CUI [2,2])
C0525058 (UMLS CUI [3])
Hypersensitivity dexamethasone acetate
Item
a known hypersensitivity to a 1.0 mg (0.5 mg per electrode) dose of dexamethasone acetate.
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
Cardiac Resynchronization Therapy | Lead, coronary venous | Ventricular Lead Left Placement Attempt
Item
previous cardiac resynchronization therapy, a coronary venous pace/sense lead or attempted lv lead placement.
boolean
C1167956 (UMLS CUI [1])
C1145020 (UMLS CUI [2])
C2825199 (UMLS CUI [3,1])
C0205091 (UMLS CUI [3,2])
C0589567 (UMLS CUI [3,3])
C1516084 (UMLS CUI [3,4])
Lead, pacemaker/cardioverter-defibrillator combination (implantable) Pre-existing
Item
pre-existing cardioversion/defibrillation leads other than those specified in this investigational plan (unless the investigator intends to replace them with permitted cardioversion/defibrillation leads).
boolean
C0993798 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
Dialysis procedure Patient need for
Item
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
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
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
a documented life expectancy of less than 6 months or expected to undergo heart transplant within 6 months.
boolean
C0023671 (UMLS CUI [1])
C0018823 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with research results
Item
enrolled in any concurrent study, without prior 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])
Mechanical heart valve Tricuspid
Item
have a mechanical tricuspid heart valve.
boolean
C0493527 (UMLS CUI [1,1])
C0443327 (UMLS CUI [1,2])