Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Pharmacotherapy Optimal
Item
moderate or severe heart failure, defined as nyha class iii-iv despite optimal pharmacological heart failure therapy
boolean
C0018801 (UMLS CUI [1,1])
C0205081 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [2,3])
C0013216 (UMLS CUI [3,1])
C2698651 (UMLS CUI [3,2])
Therapeutic procedure Heart failure | Adrenergic beta-1 Receptor Antagonists | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist
Item
on heart failure medical regimen (beta blockers and ace-i or arb's) for at least one month before randomization
boolean
C0087111 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0304516 (UMLS CUI [2])
C0003015 (UMLS CUI [3])
C0521942 (UMLS CUI [4])
QRS duration 12 lead ECG
Item
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a qrs duration > 120 ms
boolean
C0429025 (UMLS CUI [1,1])
C0430456 (UMLS CUI [1,2])
Left ventricular ejection fraction
Item
left ventricular ejection fraction (lvef) < 35% or equal
boolean
C0428772 (UMLS CUI [1])
Protocol Compliance | Insertion of therapeutic device | Participation Testing
Item
willing and capable of undergoing the device implant procedure and participating in all testing associated with this clinical study
boolean
C0525058 (UMLS CUI [1])
C0184961 (UMLS CUI [2])
C0679823 (UMLS CUI [3,1])
C0039593 (UMLS CUI [3,2])
Life Expectancy
Item
have a life expectancy of more than 180 days, per physician discretion
boolean
C0023671 (UMLS CUI [1])
Age | Age Legal | Informed Consent
Item
age 40 or above, ensuring of legal age to give informed consent specific to state and national law
boolean
C0001779 (UMLS CUI [1])
C0001779 (UMLS CUI [2,1])
C1301860 (UMLS CUI [2,2])
C0021430 (UMLS CUI [3])
Cardiac Resynchronization Therapy | Coronary venous pacing lead
Item
have had previous cardiac resynchronization therapy or a previous coronary venous lead
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
6-minute walk test Performance Unable
Item
unable to perform a six-minute hall walk (6mhw) test
boolean
C0430515 (UMLS CUI [1,1])
C1882330 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Tachyarrhythmia atrial permanent | Congenital heart block Absent | Absence Atrioventricular junction Ablation Planned
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention)without chb or planned avj ablation prior to randomization
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C0149530 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0332197 (UMLS CUI [3,1])
C0729580 (UMLS CUI [3,2])
C0547070 (UMLS CUI [3,3])
C1301732 (UMLS CUI [3,4])
Tachyarrhythmia atrial persistent | Absence Cardioversion Planned Successful
Item
have an atrial tachyarrhythmia that is persistent (i.e. can be terminated with medical intervention, but does not terminate spontaneously) without planned and successful cardioversion prior to randomization (patients with unsuccessful cardioversions and no avj ablation will be exited.)
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205322 (UMLS CUI [1,3])
C0332197 (UMLS CUI [2,1])
C0013778 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C1272703 (UMLS CUI [2,4])
Hypertrophic Obstructive Cardiomyopathy | Cardiomyopathy Infiltrating | Amyloidosis | Sarcoidosis
Item
have hypertrophic obstructive cardiomyopathy or infiltrative cardiomyopathy (e.g., amyloidosis, sarcoidosis)
boolean
C0007194 (UMLS CUI [1])
C0878544 (UMLS CUI [2,1])
C0332448 (UMLS CUI [2,2])
C0002726 (UMLS CUI [3])
C0036202 (UMLS CUI [4])
Tricuspid valve prosthesis
Item
have a mechanical tricuspid prosthesis
boolean
C3839627 (UMLS CUI [1])
Aortic Valve Stenosis Severe | Mitral Valve Stenosis Severe
Item
has severe aortic or mitral stenosis
boolean
C0003507 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0026269 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
Study Subject Participation Status Interferes with Research results
Item
enrolled in any concurrent study that may confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Pregnancy | Pregnancy Suspected | Pregnancy, Planned
Item
patients who are or suspect they may be pregnant or plan to become pregnant
boolean
C0032961 (UMLS CUI [1])
C0032961 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])
C0032992 (UMLS CUI [3])