Pacemaker-based Long-term Monitoring of Sleep Apnea

Last updated: July 31, 2024
Sponsor: Medical University Innsbruck
Overall Status: Active - Recruiting

Phase

N/A

Condition

Heart Disease

Dysrhythmia

Heart Defect

Treatment

N/A

Clinical Study ID

NCT05127720
1322/2020
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • implanted Microport TEO SR/DR or BOREA SR/DR pacemaker device

  • signed informed consent

Exclusion

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

Total Participants: 300
Study Start date:
November 30, 2021
Estimated Completion Date:
November 30, 2032

Study 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.

Connect with a study center

  • Medical University Innsbruck

    Innsbruck, Tyrol 6020
    Austria

    Active - Recruiting

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