Indication Class Implantation of CRT-D
Item
1. patient eligible with class i and iia indication for implantation of a crt-d device according to current available guidelines ;
boolean
C3146298 (UMLS CUI [1,1])
C0456387 (UMLS CUI [1,2])
C1135480 (UMLS CUI [1,3])
Heart failure Moderate New York Heart Association Classification | Heart failure Severe New York Heart Association Classification | Heart failure Ambulatory New York Heart Association Classification
Item
2. modere,severe hf (nyha class iii or ambulatory iv)
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])
C0018801 (UMLS CUI [3,1])
C1561561 (UMLS CUI [3,2])
C1275491 (UMLS CUI [3,3])
Left ventricular ejection fraction
Item
3. lvef ≤ 35 %
boolean
C0428772 (UMLS CUI [1])
Left Bundle-Branch Block | QRS duration | Left Bundle-Branch Block Absent
Item
4. lbbb: qrs ≥ 120 ms ; non-lbbb : qrs ≥ 150 ms
boolean
C0023211 (UMLS CUI [1])
C0429025 (UMLS CUI [2])
C0023211 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Pharmacotherapy Optimal Stable
Item
5. on a stable, optimal drug regimen
boolean
C0013216 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0205360 (UMLS CUI [1,3])
Sinus rhythm
Item
6. patient is in sinus rhythm at the time of enrollment;
boolean
C0232201 (UMLS CUI [1])
Informed Consent
Item
7. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Tachycardia, Ventricular | Cause Transitory | Cause Reversible | Myocardial Infarction | Digitalis intoxication | Drowning | Electrocution | Electrolyte imbalance | Hypoxia | Sepsis
Item
1. ventricular tachyarrhythmia of transient or reversible causes such as acute myocardial infarction, digitalis intoxication, drowning, electrocution, electrolyte imbalance, hypoxia or sepsis, uncorrected at the time of the enrolment;
boolean
C0042514 (UMLS CUI [1])
C0015127 (UMLS CUI [2,1])
C0205374 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C0205343 (UMLS CUI [3,2])
C0027051 (UMLS CUI [4])
C0151595 (UMLS CUI [5])
C0013142 (UMLS CUI [6])
C0277644 (UMLS CUI [7])
C0342579 (UMLS CUI [8])
C0242184 (UMLS CUI [9])
C0243026 (UMLS CUI [10])
Incessant ventricular tachycardia
Item
2. incessant ventricular tachyarrhythmia;
boolean
C2363809 (UMLS CUI [1])
Angina, Unstable | Myocardial Infarction | Coronary Artery Bypass Surgery | Percutaneous Transluminal Coronary Angioplasty
Item
3. unstable angina, or acute mi, cabg, or ptca within the past 4 weeks;
boolean
C0002965 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0010055 (UMLS CUI [3])
C2936173 (UMLS CUI [4])
Valvular disease Causing Heart failure
Item
4. correctable valvular disease that is the primary cause of heart failure;
boolean
C3258293 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])
Cerebrovascular accident Recent | Transient Ischemic Attack Recent
Item
5. recent cva or tia (within the previous 3 months);
boolean
C0038454 (UMLS CUI [1,1])
C0332185 (UMLS CUI [1,2])
C0007787 (UMLS CUI [2,1])
C0332185 (UMLS CUI [2,2])
Atrial arrhythmia Persistent | Atrial arrhythmia Permanent | ATRIAL FIBRILLATION CARDIOVERSION
Item
6. persistent or permanent atrial arrhythmias (or cardioversion for atrial fibrillation) within the past month;
boolean
C0085611 (UMLS CUI [1,1])
C0205322 (UMLS CUI [1,2])
C0085611 (UMLS CUI [2,1])
C0205355 (UMLS CUI [2,2])
C0741278 (UMLS CUI [3])
Status post Heart Transplantation
Item
7. post heart transplant (patients who are waiting for a heart transplant are allowed in the study);
boolean
C0231290 (UMLS CUI [1,1])
C0018823 (UMLS CUI [1,2])
Kidney Failure | Glomerular Filtration Rate | Dialysis
Item
8. renal failure (gfr<15 ml/min/1.73m2) or on dialysis
boolean
C0035078 (UMLS CUI [1])
C0017654 (UMLS CUI [2])
C0011946 (UMLS CUI [3])
Implantation of CRT-D Previous
Item
9. previous implant with a crt/crt-d device;
boolean
C1135480 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
Artificial cardiac pacemaker Concurrent | Implantable defibrillator Concurrent |
Item
10. concurrent implant with another pacemaker or icd (previously implanted pacemaker or icd devices or ra leads should be removed prior to implant with the paradym rf sonr crt-d);
boolean
C0030163 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0205420 (UMLS CUI [2,2])
Study Subject Participation Status | Clinical Trial | Interference Research results
Item
11. already included in another clinical study that could confound the results of this study;
boolean
C2348568 (UMLS CUI [1])
C0008976 (UMLS CUI [2])
C0521102 (UMLS CUI [3,1])
C0683954 (UMLS CUI [3,2])
Life Expectancy
Item
12. life expectancy less than 1 year;
boolean
C0023671 (UMLS CUI [1])
Study Protocol Comprehension Unable | Quality of life Questionnaire Comprehension Unable | Quality of life Questionnaire Completion Unable
Item
13. inability to understand the purpose of the study or to understand and complete the qol questionnaire;
boolean
C2348563 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
C0034380 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0162340 (UMLS CUI [2,3])
C1299582 (UMLS CUI [2,4])
C0034380 (UMLS CUI [3,1])
C0034394 (UMLS CUI [3,2])
C0205197 (UMLS CUI [3,3])
C1299582 (UMLS CUI [3,4])
Patient Unavailable Follow-up | Patient cooperation Refused
Item
14. unavailability for scheduled follow-up or refusal to cooperate;
boolean
C0030705 (UMLS CUI [1,1])
C0686905 (UMLS CUI [1,2])
C3274571 (UMLS CUI [1,3])
C1321605 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Hypersensitivity Dexamethasone sodium phosphate Dose
Item
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
C0178602 (UMLS CUI [1,3])
Age
Item
16. age of less than 18 years;
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
17. pregnancy
boolean
C0032961 (UMLS CUI [1])
Drug Dependence | Drug abuse
Item
18. drug addiction or abuse
boolean
C1510472 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
Patients Guardianship
Item
19. under guardianship
boolean
C0030705 (UMLS CUI [1,1])
C0870627 (UMLS CUI [1,2])