Bradycardia
Conditions
Brief summary
This is a prospective, non-interventional cohort study. It tests the hypothesis that * Pacemaker-derived monitoring of sleep-related breathing disorders and/or daily physical activity predicts clinical outcome. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts clinical outcome in pacemaker patients. * Autonomic imbalance defined by an increased periodic repolarisation dynamics (PRD) predicts the occurrence of device-detected atrial fibrillation and/or device-detected sleep apnea. * Enviromental factors such as ambient temperature, humidity, precipitation, air pressure impacts device-detected atrial fibrillation and/or device-detected sleep apnea. * Variation of night-to-night device-detected sleep apnea shows sex-specific patterns and impacts device-detected atrial fibrillation burden, ventricular pacing rate in sick sinus syndrome and clinical outcomes. * Burden / variation of device-detected sleep apnea and/or device-detected atrial fibrillation correlates with the incidence and severity of common ophthalmologic diseases.
Detailed description
All forms of arrhythmias, sleep apnea during sleeping hours and physical activity using sensors in modern implanted pacemakers as well as autonomic imbalance measures will be correlated with the incidence and progression (within 5 years of follow-up) of common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency. In a long follow up perspective major adverse cardiovascular events will be recorded and new risk scores will be developed, incorporating machine learning techniques.
Interventions
None listed
Sponsors
Medical University Innsbruck
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* implanted Microport TEO SR/DR or BOREA SR/DR or ALIZEA SR/DR pacemaker device * signed informed consent
Exclusion criteria
* any contraindication to perform a cardiac CT examination * eGFR \< 30 ml/min/1.73 m2 * allergy against CT contrast medium * hyperthyreoism * inability of the patient to understand the study purpose and plan * inability of the patient to perform baseline examinations * pregnancy or breast-feeding; women with childbearing potential * estimated life expectancy below one year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 3P-MACE | time to first event, follow up for 120 months | death, myocardial infarction and/or stroke |
| device-detected atrial fibrillation | time to first event, follow up for 120 months | first episode lasting more than 6 minutes or 24 hours |
| device-detected sleep apnea | after 1, 3, 5 years | severity (RDI \< versus \> 20/h) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| incidence of common opthalmological disease | assessed within the first year after study enrollment | in correlation to device-detected sleep apnea and device-detected atrial fibrillation |
| Deterioration of lung function | after 5 years | conventional lung function testing |
| Progression of subclinical peripheral artery disease | after 5 years | sonography |
| QoL assessment | after 5 years | EQ-5D-5L |
Countries
Austria
Outcome results
None listed