Criteria Following
Item
patients who meet all the following criteria at the time of enrollment may be included:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
New York Heart Association Classification | Indication Implantation of CRT-D | Guidelines
Item
1. patient with a class i and iia indication for implantation of a crt-d device according to current available guidelines
boolean
C1275491 (UMLS CUI [1])
C3146298 (UMLS CUI [2,1])
C1135480 (UMLS CUI [2,2])
C0162791 (UMLS CUI [3])
New York Heart Association Classification
Item
2. moderate/severe hf (nyha class iii or ambulatory iv)
boolean
C1275491 (UMLS CUI [1])
Left ventricular ejection fraction
Item
3. lvef ≤ 35 %
boolean
C0428772 (UMLS CUI [1])
Left Bundle-Branch Block QRS complex duration | Electrocardiogram QRS complex duration
Item
4. lbbb: qrs ≥ 120 ms ; non-lbbb : qrs ≥ 150 ms
boolean
C0023211 (UMLS CUI [1,1])
C0429025 (UMLS CUI [1,2])
C0013798 (UMLS CUI [2,1])
C0429025 (UMLS CUI [2,2])
Medication regimen Stable status
Item
5. on a stable optimal drug regimen
boolean
C0237125 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Sinus rhythm Time Informed Consent
Item
6. patient is in sinus rhythm at the time of signing the informed consent
boolean
C0232201 (UMLS CUI [1,1])
C0040223 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
Informed Consent
Item
7. signed and dated informed consent
boolean
C0021430 (UMLS CUI [1])
Criteria Following
Item
patients who meet any one of these criteria will be excluded from the investigation:
boolean
C0243161 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
Tachycardia, Ventricular | Acute myocardial infarction | Digitalis intoxication (NOS) | 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 enrollment
boolean
C0042514 (UMLS CUI [1])
C0155626 (UMLS CUI [2])
C0151595 (UMLS CUI [3])
C0013142 (UMLS CUI [4])
C0277644 (UMLS CUI [5])
C0342579 (UMLS CUI [6])
C0242184 (UMLS CUI [7])
C0243026 (UMLS CUI [8])
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 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 Etiology aspects Heart failure
Item
4. correctable valvular disease that is the primary cause of heart failure
boolean
C3258293 (UMLS CUI [1,1])
C0015127 (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])
Heart Transplantation Post
Item
7. post heart transplant (patients who are waiting for a heart transplant are allowed in the study)
boolean
C0018823 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
Kidney Failure | Glomerular Filtration Rate | Dialysis procedure
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 procedure Previous | Cardiac Resynchronization Therapy Pacemaker (CRT-P) | Cardiac Resynchronization Therapy Defibrillator (CRT-D)
Item
9. previous implant with a crt- p or crt-d device
boolean
C0021107 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C1737639 (UMLS CUI [2])
C1736558 (UMLS CUI [3])
Implantation procedure Concurrent | Artificial cardiac pacemaker | Implantable defibrillator
Item
10. concurrent implant with another pacemaker or icd system in which all or some of the components will not be extracted and/or utilized in the new system. previously implanted ra leads must be removed prior to implant of the sonrtip lead.
boolean
C0021107 (UMLS CUI [1,1])
C0205420 (UMLS CUI [1,2])
C0030163 (UMLS CUI [2])
C0162589 (UMLS CUI [3])
Study Subject Participation Status Affecting research results
Item
11. already included in another clinical study that could confound the results of this study
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])
Life Expectancy
Item
12. life expectancy less than 1 year
boolean
C0023671 (UMLS CUI [1])
Study Protocol Comprehension | Quality of life scale Questionnaires Completion
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])
C0451401 (UMLS CUI [2,1])
C0034394 (UMLS CUI [2,2])
C0205197 (UMLS CUI [2,3])
Unavailability follow-up | Cooperation Refused
Item
14. unavailability for scheduled follow-up or refusal to cooperate
boolean
C0686905 (UMLS CUI [1,1])
C1522577 (UMLS CUI [1,2])
C0392337 (UMLS CUI [2,1])
C1705116 (UMLS CUI [2,2])
Hypersensitivity Dexamethasone sodium phosphate
Item
15. sensitivity to 1 mg dexamethasone sodium phosphate (dsp)
boolean
C0020517 (UMLS CUI [1,1])
C0113286 (UMLS CUI [1,2])
Age
Item
16. age of less than 18 years
boolean
C0001779 (UMLS CUI [1])
Pregnancy
Item
17. pregnancy
boolean
C0032961 (UMLS CUI [1])
Substance Dependence | Substance Use Disorders
Item
18. substance addiction or abuse
boolean
C0038580 (UMLS CUI [1])
C0038586 (UMLS CUI [2])
guardianship
Item
19. under guardianship
boolean
C0870627 (UMLS CUI [1])