Informed consent
Item
1. informed consent;
boolean
C0021430 (UMLS CUI [1])
Chronic systolic heart failure | Left ventricular systolic dysfunction | Left ventricular ejection fraction | New York Heart Association Classification | Therapeutic procedure Optimal
Item
2. chronic systolic heart failure recognized for more than 6 months, with left ventricular systolic disfunction (ejection fraction ≤ 35%) and nyha ii-iii or ambulatory iv class symptoms despite optimal medical treatment;
boolean
C1135194 (UMLS CUI [1])
C1277187 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C1275491 (UMLS CUI [4])
C0087111 (UMLS CUI [5,1])
C2698651 (UMLS CUI [5,2])
Electrocardiography QRS complex | Left Bundle-Branch Block Morphology | QRS complex duration | Cardiac pacing Right ventricle | Atrioventricular Block Advanced chronic Stable status
Item
3. qrs complex on the surface electrocardiogram with left bundle branch block morphology and duration ≥ 120 ms, either typical or atypical or induced by right ventricular pacing due to stable chronic advanced atrio-ventricular block; qrs with with non-specific intraventricular delay lasting ≥ 150 ms;
boolean
C1623258 (UMLS CUI [1,1])
C0429097 (UMLS CUI [1,2])
C0023211 (UMLS CUI [2,1])
C0332437 (UMLS CUI [2,2])
C0429025 (UMLS CUI [3])
C0199640 (UMLS CUI [4,1])
C0225883 (UMLS CUI [4,2])
C0004245 (UMLS CUI [5,1])
C0205179 (UMLS CUI [5,2])
C0205191 (UMLS CUI [5,3])
C0205360 (UMLS CUI [5,4])
Idioventricular rhythm Regular | Atrioventricular Conduction Spontaneous | Intraventricular pacing | Implant Against Bradycardia | Sinus rhythm | Permanent atrial fibrillation | High grade atrioventricular block | Ventricular rate
Item
4. a regular ventricular rhythm, either with spontaneous atrio-ventricular conduction or with ventricular pacing via a chronically implanted antibradycardia device; with sinus rhythm unless atrial fibrillation is permanent and associated with a permanent high-degree atrio-ventricular block with a spontaneous ventricular rate constantly ≤
boolean
C0700363 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C3831454 (UMLS CUI [2,1])
C0205359 (UMLS CUI [2,2])
C0199648 (UMLS CUI [3])
C0021102 (UMLS CUI [4,1])
C0521124 (UMLS CUI [4,2])
C0428977 (UMLS CUI [4,3])
C0232201 (UMLS CUI [5])
C2586056 (UMLS CUI [6])
C2363939 (UMLS CUI [7])
C2189285 (UMLS CUI [8])
ventricular rate Beats per minute
Item
45 beats per minute;
boolean
C2189285 (UMLS CUI [1,1])
C0439385 (UMLS CUI [1,2])
Bradyarrhythmia Simultaneous | Intraventricular pacing | Cardiac Resynchronization Therapy | Artificial cardiac pacemaker | Implantable defibrillator
Item
5. no concomitant bradyarrhythmias being per se an indication for new implant ventricular pacing; upgrade to cardiac resynchronization therapy only if a previous pacemaker or implantable cardioverter-defibrillator was implanted more than 6 months previously;
boolean
C0079035 (UMLS CUI [1,1])
C0521115 (UMLS CUI [1,2])
C0199648 (UMLS CUI [2])
C1167956 (UMLS CUI [3])
C0030163 (UMLS CUI [4])
C0162589 (UMLS CUI [5])
medical condition Stable status | Hemodynamics Stable status | Implantation Cardiac Resynchronization Therapy Devices | Ventricular Heart Rate | Respiratory rate
Item
6. a stable clinical and hemodynamic condition during cardiac resynchronization therapy device implant, and at the acquisition time heat rate between 50 and 100 beats per minute and respiratory rate ≤ 25 breaths per minute;
boolean
C1699700 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0019010 (UMLS CUI [2,1])
C0205360 (UMLS CUI [2,2])
C0021107 (UMLS CUI [3,1])
C2936377 (UMLS CUI [3,2])
C1883530 (UMLS CUI [4])
C0231832 (UMLS CUI [5])
Informed Consent Unable
Item
1. inability to give informed consent;
boolean
C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
Myocardial Infarction | Repair of heart valve | Operative Surgical Procedures Heart Valves | Coronary revascularisation
Item
2. occurrence of myocardial infarction, valve repair or surgery, or coronary revascularization in the past 6 months;
boolean
C0027051 (UMLS CUI [1])
C0190112 (UMLS CUI [2])
C0543467 (UMLS CUI [3,1])
C0018826 (UMLS CUI [3,2])
C0877341 (UMLS CUI [4])
Cardiac Arrhythmia | Irregular heart beat
Item
3. any arrhythmia at the acquisition time which frequently alters the regularity of a minimum of five consecutive heart beats;
boolean
C0003811 (UMLS CUI [1])
C0237314 (UMLS CUI [2])
Study Subject Participation Status
Item
4. participation in any other competing clinical study, with the exception of registries ruled by national health service authorities or agencies, and observational studies/registries which are not conflicting and do not interfere with any of the following aspects:
boolean
C2348568 (UMLS CUI [1])
Study Subject Participation Status Interferes with Study Protocol
Item
1. the program of procedures/assessments requested by the present study;
boolean
C2348568 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C2348563 (UMLS CUI [1,3])
Study Subject Participation Status Affecting research results
Item
2. the outcome of the present study due to the requirement of medical treatments or interventions which are able to modify the clinical conditions of patients.
boolean
C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0683954 (UMLS CUI [1,3])