NCT Number: NCT05127720
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.
Interested in participating?
Request Info18 year and older
All sexes
Observational
Innsbruck, Tyrol, 6020, Austria
Location status: Recruiting
Agne Adukauskaite, MSc PhD
CONTACT
Andrea Rubatscher, MD
SUB_INVESTIGATOR
Philipp Spitaler, MD
SUB_INVESTIGATOR
Valentin Bilgeri, MD
SUB_INVESTIGATOR
Wolfgang Dichtl, MD PhD
CONTACT
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: time to first event, follow up for 120 months
death, myocardial infarction and/or stroke
Time frame: time to first event, follow up for 120 months
first episode lasting more than 6 minutes or 24 hours
Time frame: after 1, 3, 5 years
total burden
Time frame: after 1, 3, 5 years
severity (RDI < versus > 20/h)
Time frame: after 1, 3, 5 years
variation
Time frame: assessed within the first year after study enrollment
in correlation to device-detected sleep apnea and device-detected atrial fibrillation
Time frame: after 5 years
conventional lung function testing
Time frame: after 5 years
sonography
Time frame: after 5 years
ABI
Time frame: after 5 years
EQ-5D-5L
Medical University Innsbruck
Other
Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
Acronym: ACaSA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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