An observational study in Bradycardia, sponsored by Medical University Innsbruck. Recruiting at 1 site in Austria. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-24.
Sponsored by Medical University Innsbruck · Observational
This is a prospective, non-interventional cohort study. It tests the hypothesis that
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.
306 studies on the registry are indexed under Bradycardia; 69 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 257 across 129 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Medical University Innsbruck is the lead sponsor of 182 studies on the registry; 49 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with pacemakers are usually above the age of 65 years, and suffer from common co-morbidities such as arterial hypertension, coronary artery disease, heart failure, COPD, peripheral artery disease, iron insufficiency, sleep disordered breathing, obesity and/or physical inactivity / de-conditioning.
Exclusion Criteria:
defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment
defined by PRD ≥ 5.75deg2 (native) and/or ≥ 3 deg2 (paced) assessed within the first 12 months of enrollment
defined by a pacemaker-derived mean daily physical activity level \< 2h in the first 12 months after enrollment
3P-MACE
death, myocardial infarction and/or stroke
Time frame: time to first event, follow up for 120 months
device-detected atrial fibrillation
first episode lasting more than 6 minutes or 24 hours
Time frame: time to first event, follow up for 120 months
device-detected atrial fibrillation
total burden
Time frame: after 1, 3, 5 years
device-detected sleep apnea
severity (RDI \< versus \> 20/h)
Time frame: after 1, 3, 5 years
device-detected sleep apnea
variation
Time frame: after 1, 3, 5 years
incidence of common opthalmological disease
in correlation to device-detected sleep apnea and device-detected atrial fibrillation
Time frame: assessed within the first year after study enrollment
Deterioration of lung function
conventional lung function testing
Time frame: after 5 years
Progression of subclinical peripheral artery disease
sonography
Time frame: after 5 years
Progression of subclinical peripheral artery disease
ABI
Time frame: after 5 years
QoL assessment
EQ-5D-5L
Time frame: after 5 years
Documents are hosted by the registry — open the source record to download them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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Medical University Innsbruck