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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| patients with severe sleep apnea | defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment | ||
| patients with autonomic imbalance | defined by PRD ≥ 5.75deg2 (native) and/or ≥ 3 deg2 (paced) assessed within the first 12 months of enrollment | ||
| patients with a sedentary lifestyle | defined by a pacemaker-derived mean daily physical activity level < 2h in the first 12 months after enrollment |
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| Measure | Description | Time Frame |
|---|---|---|
| 3P-MACE | death, myocardial infarction and/or stroke | time to first event, follow up for 120 months |
| device-detected atrial fibrillation | first episode lasting more than 6 minutes or 24 hours | time to first event, follow up for 120 months |
| device-detected atrial fibrillation | total burden | after 1, 3, 5 years |
| device-detected sleep apnea | severity (RDI < versus > 20/h) | after 1, 3, 5 years |
| device-detected sleep apnea | variation | after 1, 3, 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| incidence of common opthalmological disease | in correlation to device-detected sleep apnea and device-detected atrial fibrillation | assessed within the first year after study enrollment |
| Deterioration of lung function |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University Innsbruck | Recruiting | Innsbruck | Tyrol | 6020 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20625114 | Result | Gottlieb DJ, Yenokyan G, Newman AB, O'Connor GT, Punjabi NM, Quan SF, Redline S, Resnick HE, Tong EK, Diener-West M, Shahar E. Prospective study of obstructive sleep apnea and incident coronary heart disease and heart failure: the sleep heart health study. Circulation. 2010 Jul 27;122(4):352-60. doi: 10.1161/CIRCULATIONAHA.109.901801. Epub 2010 Jul 12. | |
| 25307200 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 17, 2025 | Feb 19, 2026 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D001919 | Bradycardia |
| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
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conventional lung function testing
| after 5 years |
| Progression of subclinical peripheral artery disease | sonography | after 5 years |
| Progression of subclinical peripheral artery disease | ABI | after 5 years |
| QoL assessment | EQ-5D-5L | after 5 years |
| Luyster FS, Kip KE, Aiyer AN, Reis SE, Strollo PJ Jr. Relation of obstructive sleep apnea to coronary artery calcium in non-obese versus obese men and women aged 45-75 years. Am J Cardiol. 2014 Dec 1;114(11):1690-4. doi: 10.1016/j.amjcard.2014.08.040. Epub 2014 Sep 16. |
| 25515104 | Result | Hla KM, Young T, Hagen EW, Stein JH, Finn LA, Nieto FJ, Peppard PE. Coronary heart disease incidence in sleep disordered breathing: the Wisconsin Sleep Cohort Study. Sleep. 2015 May 1;38(5):677-84. doi: 10.5665/sleep.4654. |
| 24561163 | Result | Defaye P, de la Cruz I, Marti-Almor J, Villuendas R, Bru P, Senechal J, Tamisier R, Pepin JL. A pacemaker transthoracic impedance sensor with an advanced algorithm to identify severe sleep apnea: the DREAM European study. Heart Rhythm. 2014 May;11(5):842-8. doi: 10.1016/j.hrthm.2014.02.011. Epub 2014 Feb 19. |
| 31493591 | Result | Marti-Almor J, Marques P, Jesel L, Garcia R, Di Girolamo E, Locati F, Defaye P, Venables P, Dompnier A, Barcelo A, Nagele H, Burri H. Incidence of sleep apnea and association with atrial fibrillation in an unselected pacemaker population: Results of the observational RESPIRE study. Heart Rhythm. 2020 Feb;17(2):195-202. doi: 10.1016/j.hrthm.2019.09.001. Epub 2019 Sep 4. |
| 27890735 | Result | Moubarak G, Bouzeman A, de Geyer d'Orth T, Bouleti C, Beuzelin C, Cazeau S. Variability in obstructive sleep apnea: Analysis of pacemaker-detected respiratory disturbances. Heart Rhythm. 2017 Mar;14(3):359-364. doi: 10.1016/j.hrthm.2016.11.033. Epub 2016 Nov 23. |
| 33179808 | Result | Mazza A, Bendini MG, Leggio M, De Cristofaro R, Valsecchi S, Boriani G. Continuous monitoring of sleep-disordered breathing with pacemakers: Indexes for risk stratification of atrial fibrillation and risk of stroke. Clin Cardiol. 2020 Dec;43(12):1609-1615. doi: 10.1002/clc.23489. Epub 2020 Nov 12. |
| 31221356 | Result | Linz D, Brooks AG, Elliott AD, Nalliah CJ, Hendriks JML, Middeldorp ME, Gallagher C, Mahajan R, Kalman JM, McEvoy RD, Lau DH, Sanders P. Variability of Sleep Apnea Severity and Risk of Atrial Fibrillation: The VARIOSA-AF Study. JACC Clin Electrophysiol. 2019 Jun;5(6):692-701. doi: 10.1016/j.jacep.2019.03.005. Epub 2019 May 1. |
| 28073884 | Result | Mazza A, Bendini MG, De Cristofaro R, Lovecchio M, Valsecchi S, Boriani G. Pacemaker-detected severe sleep apnea predicts new-onset atrial fibrillation. Europace. 2017 Dec 1;19(12):1937-1943. doi: 10.1093/europace/euw371. |
| D013568 |
| Pathological Conditions, Signs and Symptoms |