Pacemaker-based Long-term Monitoring of Sleep Apnea

Bradycardia Clinical Trial

— ACaSA  

Official title:

Schrittmacher-basiertes Schlafapnoe Langzeit-Monitoring

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05127720
• Other study ID #: 1322/2020
• Status: Recruiting
• Start date: November 30, 2021
• Est. completion date: November 30, 2032

Study information

• Verified date: March 2023
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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 AHRE in SR patients implanted with a DDDR pacemaker.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: November 30, 2032
• Est. primary completion date: November 30, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• implanted Microport TEO SR/DR or BOREA 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

Related Conditions & MeSH terms

• Bradycardia

Locations

Country	Name	City	State
Austria	Medical University Innsbruck	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

References & Publications (9)

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- — View Citation

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 — View Citation

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. — View Citation

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. 2 — View Citation

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. Epu — View Citation

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 o — View Citation

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. — View Citation

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 — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	3P-MACE	death, myocardial infarction and/or stroke	after 3 years
Primary	3P-MACE	death, myocardial infarction and/or stroke	after 5 years
Primary	3P-MACE	death, myocardial infarction and/or stroke	after 10 years
Primary	Atrial high rate episodes	in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration	after 3 years
Primary	Atrial high rate episodes	in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration	after 5 years
Primary	Atrial high rate episodes	in patients with sinus rhythm and implanted DDDR pacemaker; > 6 min duration	after 10 years
Primary	Ventricular tachyarrhythmia	cycle length < 320 ms; = 40 beats	after 3 years
Primary	Ventricular tachyarrhythmia	cycle length < 320 ms; = 40 beats	after 5 years
Primary	Ventricular tachyarrhythmia	cycle length < 320 ms; = 40 beats	after 10 years
Secondary	Progression of subclinical coronary atherosclerosis assessed by CTA	Agatston-Score stratified to 0, 1-10, 11-100, 101-400, >400. Coronary lesions will be graded according to the CADSRAD classification (minimal < 10%, mild < 50%, moderate 50-70%, severe > 70%). Coronary plaques will be classified as T1 = calcified, T2 = mixed, T3 = mixed, primarily calcified, T4 = non-calcified). "High risk plaque"-criteria will include: low attenuation plaque, napkin-ring, spotty calcification < 3mm, remodelling index.	after 5 years
Secondary	Deterioration of lung function	conventional lung function testing	after 5 years
Secondary	Progression of subclinical peripheral artery disease	sonography	after 5 years
Secondary	Progression of subclinical peripheral artery disease	ABI	after 5 years
Secondary	QoL assessment	EQ-5D-5L	after 5 years