Pacemaker-based Long-term Monitoring of Sleep Apnea (ACaSA)

Medical University Innsbruck

Status: Enrolling

Conditions: Bradycardia

Study type: Observational

Funder types: Other

Identifiers

NCT05127720

1322/2020

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

300 participants in 3 patient groups

patients with severe sleep apnea

Description:

defined by a pacemaker-derived mean RDI ≥ 20/h in the first 12 months after enrollment

patients with autonomic imbalance

Description:

defined by PRD ≥ 5.75deg2 assessed within the first 12 months of enrollment

patients with a sedentary lifestyle

Description:

defined by a pacemaker-derived mean daily physical activity level \< 2h in the first 12 months after enrollment