Indication Cardiac Resynchronization Therapy | Indication Implantation of CRT-D
Item
subject is indicated for crt or crt-d device according to current applicable esc/aha guidelines
boolean
C3146298 (UMLS CUI [1,1])
C1167956 (UMLS CUI [1,2])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
Sinus rhythm Stable | Atrial arrhythmia Duration | Episode of Atrial Fibrillation Absent
Item
subject is in stable sinus rhythm at the time of implant (no atrial arrhythmias lasting > 30 seconds during the last 2 weeks prior to inclusion). no documented af-episodes allowed during the last 2 weeks prior to inclusion.
boolean
C0232201 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0085611 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0332189 (UMLS CUI [3,1])
C0004238 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Therapy Oral Optimal Heart failure | Angiotensin-Converting Enzyme Inhibitors | Angiotensin II receptor antagonist | Adrenergic beta-1 Receptor Antagonists | Pharmaceutical Preparations Stable
Item
subject receives optimal heart failure oral medical therapy (ace inhibitor and/or arb and beta blockers), and is on a stable medication scheme for at least 2 months prior to enrollment.
boolean
C0087111 (UMLS CUI [1,1])
C1527415 (UMLS CUI [1,2])
C2698651 (UMLS CUI [1,3])
C0018801 (UMLS CUI [1,4])
C0003015 (UMLS CUI [2])
C0521942 (UMLS CUI [3])
C0304516 (UMLS CUI [4])
C0013227 (UMLS CUI [5,1])
C0205360 (UMLS CUI [5,2])
Informed Consent | Informed Consent Legal Guardian
Item
subject (or the legal guardian) is willing to sign informed consent form
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0023226 (UMLS CUI [2,2])
Permanent atrial fibrillation | Atrial Flutter Permanent | Atrial tachycardia Permanent
Item
permanent atrial fibrillation/ flutter or tachycardia
boolean
C2586056 (UMLS CUI [1])
C0004239 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0546959 (UMLS CUI [3,1])
C0205355 (UMLS CUI [3,2])
Right bundle branch block
Item
rbbb
boolean
C0085615 (UMLS CUI [1])
Recent myocardial infarction | Coronary Artery Bypass Surgery | Valve Surgery
Item
recent myocardial infarction (mi), within 40 days prior to enrollment. subject underwent coronary artery bypass graft (cabg) or valve surgery, within 90 days prior to enrollment
boolean
C1998297 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
C1186983 (UMLS CUI [3,1])
C0543467 (UMLS CUI [3,2])
Status post Heart Transplantation | Patient on waiting list Transplantation | Transplantation Expected
Item
post heart transplantation, or is actively listed on the transplantation list, or has reasonable probability (per investigator's discretion) of undergoing transplantation in the next year
boolean
C0231290 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
C0422768 (UMLS CUI [2,1])
C0040732 (UMLS CUI [2,2])
C0040732 (UMLS CUI [3,1])
C1517001 (UMLS CUI [3,2])
Implantation of left ventricular assist device | Implantation of left ventricular assist device Expected
Item
implanted with a left ventricular assist device (lvad), or has reasonable probability (per investigator's discretion) of receiving a lvad in the next year
boolean
C0397130 (UMLS CUI [1])
C0397130 (UMLS CUI [2,1])
C1517001 (UMLS CUI [2,2])
Dialysis chronic | Kidney Disease Severe | GFR estimation by MDRD
Item
on chronic renal dialysis, or with severe renal disease (defined as estimated glomerular filtration rate (equation provided by modification of diet in renal disease study): (egfr) < 30 ml/min/1.73m2)
boolean
C0743165 (UMLS CUI [1])
C0022658 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C2170215 (UMLS CUI [3])
Inotropic agent Infusion Heart failure | Infusion Stable times per week
Item
on continuous or uninterrupted infusion (inotropic) therapy for heart failure (≥ 2 stable infusions a week)
boolean
C0304509 (UMLS CUI [1,1])
C0574032 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
C0574032 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0456698 (UMLS CUI [2,3])
Aortic stenosis, severe | Valve Area | Valvular disease | Operative Surgical Procedure Expected
Item
severe aortic stenosis (with a valve area of <1.0 cm2 or significant valve disease expected to be operated on within study period)
boolean
C3806272 (UMLS CUI [1])
C1186983 (UMLS CUI [2,1])
C0205146 (UMLS CUI [2,2])
C3258293 (UMLS CUI [3])
C0543467 (UMLS CUI [4,1])
C1517001 (UMLS CUI [4,2])
Complex congenital heart disease uncorrected
Item
complex and uncorrected congenital heart disease
boolean
C0744669 (UMLS CUI [1,1])
C4072785 (UMLS CUI [1,2])
Mechanical heart valve
Item
mechanical heart valve
boolean
C0493527 (UMLS CUI [1])
Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control
boolean
C0006147 (UMLS CUI [1])
C3831118 (UMLS CUI [2,1])
C0700589 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Study Subject Participation Status | Clinical Trials Quantity | Interference Research results
Item
enrolled in one or more concurrent studies that would confound the results of this study
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0521102 (UMLS CUI [3,1])
C0683954 (UMLS CUI [3,2])
Pacemaker implant | Cardiac Resynchronization Therapy | Implantation of CRT-D | Implantable defibrillator | Replacement Needed
Item
already implanted with pacemaker (crt, crt-d, icd) and needs replacement
boolean
C0848753 (UMLS CUI [1])
C1167956 (UMLS CUI [2])
C1135480 (UMLS CUI [3])
C0162589 (UMLS CUI [4])
C0559956 (UMLS CUI [5,1])
C0027552 (UMLS CUI [5,2])