Indication General CRT-D device
Item
meet the general indications for a crt-d device
boolean
C3146298 (UMLS CUI [1,1])
C0205246 (UMLS CUI [1,2])
C1736558 (UMLS CUI [1,3])
Heart failure Moderate | Heart failure Severe | New York Heart Association Classification | Heart failure 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])
C0018801 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C1275491 (UMLS CUI [3])
C0018801 (UMLS CUI [4,1])
C0013216 (UMLS CUI [4,2])
C2698651 (UMLS CUI [4,3])
12 lead ECG | Sinus rhythm | QRS duration | P-R interval | P wave duration
Item
a 12-lead electrocardiogram (ecg) obtained no more than 90 days prior to enrollment documenting a sinus rate > 50 bpm, qrs duration ³ 150 ms, and pr interval £ 320 ms measured from any two leads, and a p-wave duration < 150 ms measured from lead v1
boolean
C0430456 (UMLS CUI [1])
C0232201 (UMLS CUI [2])
C0429025 (UMLS CUI [3])
C0429087 (UMLS CUI [4])
C0429021 (UMLS CUI [5])
Creatinine measurement, serum
Item
creatinine £ 2.5 mg/dl obtained no more than 14 days prior to enrollment
boolean
C0201976 (UMLS CUI [1])
Left ventricular ejection fraction | Echocardiography | Multiple gated acquisition scanning | Cardiac Catheterization
Item
left ventricular ejection fraction £ 35% [measured by echo, multiple gated acquisition (muga) scan, cardiac catheterization, etc.] no more than 14 days prior to enrollment
boolean
C0428772 (UMLS CUI [1])
C0013516 (UMLS CUI [2])
C0521317 (UMLS CUI [3])
C0018795 (UMLS CUI [4])
Device implant Capability | Protocol Compliance
Item
willing and capable of undergoing a device implant and participating in all testing associated with this clinical investigation
boolean
C0948629 (UMLS CUI [1,1])
C2698977 (UMLS CUI [1,2])
C0525058 (UMLS CUI [2])
Life Expectancy
Item
have a life expectancy of more than 180 days, per physician discretion
boolean
C0023671 (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])
Right bundle branch block morphology | 12 lead ECG
Item
right bundle branch block morphology (per world health organization guidelines) on a 12-lead ecg obtained no more than 90 days prior to enrollment.
boolean
C0085615 (UMLS CUI [1,1])
C0543482 (UMLS CUI [1,2])
C0430456 (UMLS CUI [2])
Cardiac Resynchronization Therapy | Coronary venous pacing lead | Indication General Cardiac pacing Against Bradycardia
Item
have had previous cardiac resynchronization therapy, a previous coronary venous lead, or meet the general indications for antibradycardia pacing
boolean
C1167956 (UMLS CUI [1])
C3874606 (UMLS CUI [2])
C3146298 (UMLS CUI [3,1])
C0205246 (UMLS CUI [3,2])
C0199640 (UMLS CUI [3,3])
C0521124 (UMLS CUI [3,4])
C0428977 (UMLS CUI [3,5])
Neuromuscular Disease Preventing Walking Normal | orthopedic problem Preventing Walking Normal | Other medical condition Preventing Walking Normal
Item
have a neuromuscular, orthopedic, or other non-cardiac condition that prevents normal, unsupported walking
boolean
C0027868 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0080331 (UMLS CUI [1,3])
C0205307 (UMLS CUI [1,4])
C0029354 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0080331 (UMLS CUI [2,3])
C0205307 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C1292733 (UMLS CUI [3,2])
C0080331 (UMLS CUI [3,3])
C0205307 (UMLS CUI [3,4])
Tachyarrhythmia Atrial Permanent | Tachyarrhythmia Atrial persistent
Item
have an atrial tachyarrhythmia that is permanent (i.e., does not terminate spontaneously and cannot be terminated with medical intervention) or persistent (i.e., can be terminated with medical intervention, but does not terminate spontaneously) within 180 days prior to enrollment
boolean
C0080203 (UMLS CUI [1,1])
C0018792 (UMLS CUI [1,2])
C0205355 (UMLS CUI [1,3])
C0080203 (UMLS CUI [2,1])
C0018792 (UMLS CUI [2,2])
C0205322 (UMLS CUI [2,3])
Hypersensitivity dexamethasone acetate
Item
have a hypersensitivity to a 0.7 mg dose of dexamethasone acetate
boolean
C0020517 (UMLS CUI [1,1])
C0057598 (UMLS CUI [1,2])
primary valvular heart disease uncorrected Surgical
Item
have surgically uncorrected primary valvular heart disease
boolean
C2064629 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
C0543467 (UMLS CUI [1,3])
Dialysis procedure Patient need for
Item
currently requiring dialysis
boolean
C0011946 (UMLS CUI [1,1])
C0686904 (UMLS CUI [1,2])
Chronic Obstructive Airway Disease | Forced expired volume in one second/forced vital capacity ratio
Item
have chronic obstructive pulmonary disease (copd), defined as fev1/fvc < 60%
boolean
C0024117 (UMLS CUI [1])
C0429745 (UMLS CUI [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 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])
Tricuspid valve prosthesis, device
Item
have a mechanical tricuspid prosthesis
boolean
C1322659 (UMLS CUI [1])
Study Subject Participation Status Interferes with research results
Item
enrolled in any concurrent study, 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])