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Clinical Trials in Denmark / NCT05856799
Active, not recruiting Not applicable

Danish Randomized Trial on Leadless vs Transvenous Pacing

NCT05856799 · tracked via the Priya Life Science Denmark tracker
Sponsor
University of Aarhus
Phase
Not applicable
Started
2023-09-01
Last updated
2026-04-29

Condition(s) studied

AV Block

Investigational drug(s) / intervention(s)

Leadless Micra AV Transcatheter Pacing SystemTransvenous Azure XT DR dual chamber pacemaker

Leadless Micra AV Transcatheter Pacing System: Patients are implanted with a leadless Micra AV TPS

Transvenous Azure XT DR dual chamber pacemaker: Patients are implanted with a transvenous Azure XT DR pacemaker

Study summary

The purpose of this study is to evaluate the quality of life, patient acceptance and exercise capacity with leadless compared to transvenous pacing in elderly patients with new-onset high-grade atrioventricular block. Consecutive patients with high-grade atrioventricular black and preserved sinus node function with indication for permanent pacemaker implantation according to the latest european guidelines, are included in a prospective, partly patient and accessor blinded and partly open label, 1:1 randomized combined parallel and cross-over trial to implantation with 1) a Micra AV Transcathter Pacing System or 2) an Azure XT DR dual chamber pacemaker.

Eligibility

Sex
ALL
Min age
75 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * First time pacemaker implantation on class I or II ESC recommendations for AVB with an expected amount of right ventricular pacing \>80% of the time, * Age 75 years or older * Intact sinus node function * Expected survival more than 12 months based on clinical evaluation * Able to provide informed consent Exclusion criteria: * Persistent or previous cardiac implantable electronic device i.e., pacemaker, ICD, or CRT. * Persistent, or chronic atrial fibrillation * Reversible AVB * Transient AVB due to ongoing ischemia * Heart failure NYHA class III-IV * Heart failure with branch block and indication for CRT implantation, irrespective of NYHA class * Indication for primary or secondary prophylactic ICD implantation * Acute myocardial infarction (AMI) within 3 months * Severe chronic pulmonary disease with pulmonal hypertension limiting exercise capacity * Expected survival \< 12 months based on clinical evaluation * Performing high intensity sport * Participation in another trial with experimental treatment * Contraindication against device implantation (e.g., concurrent infection) * Failure to provide informed consent

Primary outcome measure(s)

  • Quality of Life by SF36 — 7 months
    Self-reported health-related quality of life as measured by Short-Form 36 quality of life questionnaire. The scale ranges from 0 to 100. 0 denotes minimal quality of life and 100 denotes maximum quality of life.

Trial sites (2)

FacilityCityRegionStatus
Department of Cardiology Aarhus University Hospital Aarhus Region Midt
Department of Cardiology Odense University Hospital Odense Region Syd

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05856799 on ClinicalTrials.gov ↗ ← All trials in Denmark