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Danish Randomized Trial on Leadless vs Transvenous Pacing
Sponsor: University of Aarhus
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.
Official title: Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
Key Details
Gender
All
Age Range
75 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2023-08-25
Completion Date
2026-06
Last Updated
2025-04-01
Healthy Volunteers
No
Conditions
Interventions
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
Locations (2)
Department of Cardiology Aarhus University Hospital
Aarhus, Region Midt, Denmark
Department of Cardiology Odense University Hospital
Odense, Region Syd, Denmark