Pacemaker-based Long-term Monitoring of Sleep Apnea

Recruiting

• Conditions: Bradycardia

• Registration Number: NCT05127720
• Lead Sponsor: Medical University Innsbruck

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2021-10-27
• Study First Submitted QC: 2021-11-08
• Study First Posted: 2021-11-19
• Study Start: 2021-11-30
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-31
• Last Update Posted: 2024-08-01
• Primary Completion: 2031-11-30
• Study Completion: 2032-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Atrial high rate episodes	after 10 years	in patients with sinus rhythm and implanted DDDR pacemaker; \> 6 min duration
Ventricular tachyarrhythmia	after 10 years	cycle length \< 320 ms; ≥ 40 beats
3P-MACE	after 10 years	death, myocardial infarction and/or stroke

Secondary Outcome Measures

Name	Time	Method
Progression of subclinical peripheral artery disease	after 5 years	ABI
Deterioration of lung function	after 5 years	conventional lung function testing
Progression of subclinical coronary atherosclerosis assessed by CTA	after 5 years	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.
QoL assessment	after 5 years	EQ-5D-5L

Trial Locations

Locations (1)

Medical University Innsbruck; 🇦🇹 Innsbruck, Tyrol, Austria