Indication Quantity
Item
subject must have one of the following clinical indications:
boolean
C3146298 (UMLS CUI [1,1])
C1265611 (UMLS CUI [1,2])
Chronic atrial fibrillation | Second degree atrioventricular block | Complete atrioventricular block | Bifascicular bundle branch block
Item
1. chronic atrial fibrillation with 2 or 3° av or bifascicular bundle branch block (bbb block) ; or
boolean
C0694539 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0264914 (UMLS CUI [4])
Normal sinus rhythm | Second degree atrioventricular block | Complete atrioventricular block | Bundle-Branch Block | Physical activity decreased | Life Expectancy Short
Item
2. normal sinus rhythm with 2 or 3° av or bbb block and a low level of physical activity or short expected lifespan (but at least one year); or
boolean
C0232202 (UMLS CUI [1])
C0264906 (UMLS CUI [2])
C0151517 (UMLS CUI [3])
C0006384 (UMLS CUI [4])
C0391853 (UMLS CUI [5])
C0023671 (UMLS CUI [6,1])
C1806781 (UMLS CUI [6,2])
Sinus bradycardia | Pauses Infrequent | Syncope Unexplained | Electrophysiology Finding
Item
3. sinus bradycardia with infrequent pauses or unexplained syncope with ep findings; and
boolean
C0085610 (UMLS CUI [1])
C0489607 (UMLS CUI [2,1])
C0521114 (UMLS CUI [2,2])
C0039070 (UMLS CUI [3,1])
C4288071 (UMLS CUI [3,2])
C1446476 (UMLS CUI [4,1])
C0243095 (UMLS CUI [4,2])
Age
Item
subject ≥18 years of age;
boolean
C0001779 (UMLS CUI [1])
Life Expectancy
Item
subject has life expectancy of at least one year;
boolean
C0023671 (UMLS CUI [1])
Enrollment Absent Clinical Trial Other
Item
subject is not enrolled in another clinical investigation;
boolean
C1516879 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C0008976 (UMLS CUI [1,3])
C0205394 (UMLS CUI [1,4])
Protocol Compliance
Item
subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams;
boolean
C0525058 (UMLS CUI [1])
Informed Consent
Item
subject has been informed of the nature of the study, agrees to its provisions and has provided written informed consent, approved by the ec;
boolean
C0021430 (UMLS CUI [1])
Gender Contraceptive methods | Postoperative Period | Gender Sexual Abstinence | Female Sterilization | Postmenopausal state
Item
if female, for 3 months post-operative, subject will actively practice a contraception method, or will practice abstinence, or is surgically sterilized, or is postmenopausal.
boolean
C0079399 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032790 (UMLS CUI [2])
C0079399 (UMLS CUI [3,1])
C0036899 (UMLS CUI [3,2])
C0015787 (UMLS CUI [4])
C0232970 (UMLS CUI [5])
Artificial cardiac pacemaker dependent
Item
pacemaker dependent;
boolean
C0030163 (UMLS CUI [1,1])
C3244310 (UMLS CUI [1,2])
Cardiac pacemaker syndrome | Ventriculo-atrial conduction Retrograde | Hypotension Due to Intraventricular pacing
Item
known pacemaker syndrome, have retrograde va conduction or suffer a drop in arterial blood pressure with the onset of ventricular pacing;
boolean
C0340929 (UMLS CUI [1])
C2021176 (UMLS CUI [2,1])
C0439784 (UMLS CUI [2,2])
C0020649 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0199648 (UMLS CUI [3,3])
Hypersensitivity Dexamethasone sodium phosphate Dosage
Item
hypersensitivity to < 1 mg of dexamethasone sodium phosphate;
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Tricuspid valve prosthesis
Item
mechanical tricuspid valve prosthesis;
boolean
C1322659 (UMLS CUI [1])
Pulmonary arterial hypertension Pre-existing | Lung disease Impairing
Item
pre-existing pulmonary arterial (pa) hypertension or significant physiologically-impairing lung disease;
boolean
C2973725 (UMLS CUI [1,1])
C2347662 (UMLS CUI [1,2])
C0024115 (UMLS CUI [2,1])
C0221099 (UMLS CUI [2,2])
Cardiac pacing Leads Pre-existing | Defibrillation Leads Pre-existing
Item
pre-existing pacing or defibrillation leads;
boolean
C0199640 (UMLS CUI [1,1])
C0181586 (UMLS CUI [1,2])
C2347662 (UMLS CUI [1,3])
C0013778 (UMLS CUI [2,1])
C0181586 (UMLS CUI [2,2])
C2347662 (UMLS CUI [2,3])
Implantable defibrillator insertion | Cardiac Resynchronization Therapy
Item
current implantation of an implantable cardioverter defibrillator (icd) or cardiac resynchronization therapy (crt);
boolean
C0877213 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
Vena cava filter insertion
Item
presence of implanted vena cava filter;
boolean
C0877093 (UMLS CUI [1])
Leadless cardiac pacemaker Implanted
Item
presence of implanted leadless cardiac pacemaker;
boolean
C4064686 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
Pregnancy | Breast Feeding
Item
pregnant or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])