Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring
Conditions: Bradycardia
Sponsor: Medical University Innsbruck

ACaSA 
17.02.2025 
 
1.5 
 
Synopsis 
Title 
 
Pacemaker-based long-term monitoring of sleep apnea 
 
Medical Device 
 
Microport TEO® SR/DR, Microport BOREA® SR/DR, 
Microport ALIZEA® SR/DR 
 
Indication 
 
Pacemaker implantation according to current ESC guidelines  
 
Study design 
 
prospective non-interventional cohort study 
 
Location 
 
multicenter 
 
Duration of the clinical trial / 
schedule 
Recruitment time: 10 years 
Planned first patient first visit (FPFV): November 2021 
Planned last patient last visit (LPLV): December 2041 
Treatment duration 5 - 20 years 
Discriminators 
 
• 
severe sleep apnea, defined by an average RDI 
≥20/h measured by pacemaker system in the first 
year after study inclusion (= observation phase).  
• 
autonomic cardiac dysfunction defined by a PRD ≥ 
5.75 deg2 (nativ) or ≥ 3 deg2 (paced) measured by 
20-minute risk ECG in the first year after study 
inclusion (= observation phase). 
• 
physical inactivity, defined by an average of < 2 
hours of daily exercise measured by pacemaker 
system in the first year after study inclusion (= 
observation phase).   
 
Primary objective 
• 
Time to first occurrence of 3P-MACE (spontaneous 
myocardial infarction, stroke or death), follow up for 
120 months 
• 
Time to first device-detected atrial fibrillation (first 
epidoe lasting more than 6 minutes or 24 hours(, 
follow up for 120 months 
• 
Total burden of device-detected atrial fibrillation after 
1, 3, 5 years 
• 
Incidence of severe device-detected sleep apnea 
(RDI ≥ 20/h) after 1, 3, 5 years 
• 
Variability of device-detected sleep apnea after 1, 3, 
5 years 
 
Secondary objectives  
• 
Incidence of common opthalmological diseases in 
correlation to device-detected sleep apnea and 
device-detected atrial fibrillation, assessed within the 
first year after study enrolment 
• 
Deterioration of lung function conventional lung 
function testing after 5 years 
• 
Progression of subclinical peripheral artery disease, 
assessed by sonography, after 5 years 
• 
Progression of subclinical peripheral artery disease, 
assessed by ABI, after 5 years 

ACaSA 
17.02.2025 
 
1.5 
 
• 
QoL assessment by EQ-5D-5L questionnaires, after 
5 years (compared to baseline) 
 
Sample size 
 
1000 
 
Inclusion criteria /  
Exclusion criteria 
 
Inclusion criteria: 
• 
Patients with an implanted Microport TEO® SR/DR, 
BOREA® SR/DR, ALIZEA® SR/DR pacemaker and a fully 
functional system 
• 
Signed informed consent from the patient 
 
Exclusion criteria: 
• 
end-stage kidney disease (eGFR < 15 ml/min/1.73 m2) 
or renal-replacement therapy  
• 
Addiction or another disease that does not allow the 
patient to assess the nature and scope as well as 
possible consequences of the clinical trial. 
• 
Indications that the patient is unlikely to comply with the 
protocol (e.g., unwillingness to cooperate, inability to 
complete follow-up examinations). 
• 
Women of childbearing age 
• 
Women in pregnancy or lactation period  
• 
Life expectancy < 1 year 
 
Study timeline 
 
Visit 1: Inclusion and obtaining written / verbal consent. 
Pacemaker follow-up. Start of telemedical monitoring of the 
pacemaker system using SMARTVIEW® technology. 
 
Visit 2: Pacemaker follow-up within the first year. 
Performance and discussion of the examinations (20 min risk 
ECG, laboratory tests, TTE, questionnaires ESS & STOP 
Bang & EQ-5D-5L; optional spirometry, ABPM, sonography 
of the peripheral vessels with ABI measurement, 
ophthalmologic examinations). 
 
Visit 3: Pacemaker follow-up after 5 to 7 years. Discussion 
and optimization of telemedical monitoring of the pacemaker 
system using SMARTVIEW® technology. Performance and 
discussion of examinations (20 min risk ECG, laboratory 
tests, TTE, questionnaires ESS & STOP Bang & EQ-5D-5L; 
optional spirometry, ABPM, sonography of peripheral vessels 
with ABI measurement, ophthalmologic examinations).  
 
End of study: The end will occur at the scheduled end of 
study in December 2041.  
   
Statistical methods and analysis  
 
Kaplan-Meier curves are generated with respect to the 
primary combined and secondary endpoints and analysed 
with Cox proportional hazards models. Univariable and 
multivariable regression models are used to analyse 
multifactorial risk stratification, as are ROC analyses.  
 
 

 
 
ACaSA 
17.02.2025 
1.5 
 
Study timeline 
Ö *  optional; Ö §   The following laboratory values must be measured: hs-TnT, NT-proBNP, ferritin, transferrin saturation, hemoglobin, GGT, sodium, potassium, 
creatinine, urea, eGFR, CRP, leukocytes, platelets, total cholesterol, LDL cholesterol, HDL cholesterol, trigylcerides, Lp(a). 
 
 
 
1 
Tag X 
2 
 in the first year (= 
observation 
period) 
3 
after 5-7 years 
 
End of study 
Informed consent, inclusion/exclusion criteria 
Ö 
 
 
 
Demographics 
Ö 
Ö 
Ö 
Ö 
Medical history, AEs and SAEs 
Ö 
Ö 
Ö 
Ö 
Concomitant medication, comorbidities 
Ö 
Ö 
Ö 
Ö 
On-site pacemaker follow-up  
Ö 
Ö 
Ö 
 
Start, discussion and optimization of telemedical monitoring (SMARTVIEW®). 
Ö 
Ö 
Ö 
 
Venous blood draw 
 
Ö§ 
Ö§ 
 
TTE 
 
Ö 
Ö 
 
20 min risk ECG 
 
Ö 
Ö 
 
Questionnaires (EQ-5D-5L, ESS, STOP Bang) 
 
Ö  
Ö 
 
Ophthalmologic examinations 
 
Ö * 
Ö * 
 
Spirometry 
 
Ö * 
Ö * 
 
Angiological assessment (sonography, ABI) 
 
Ö * 
Ö * 
 

 
 
ACaSA 
17.02.2025 
1.5 
 

 
 
ACaSA 
17.02.2025 
 
ACaSA 
ClinicalTrials.gov: NCT05127720