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Danish Randomized Trial on VDD Leadless Atrial Tracking With MicraTM AV Transcatheter Pacing System vs Transvenous DDD Pacing in Elderly Patients With AV-block
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.
Age
75 - No limit years
Sex
ALL
Healthy Volunteers
No
Department of Cardiology Aarhus University Hospital
Aarhus, Region Midt, Denmark
Department of Cardiology Odense University Hospital
Odense, Region Syd, Denmark
Start Date
August 25, 2023
Primary Completion Date
November 1, 2025
Completion Date
June 1, 2026
Last Updated
April 1, 2025
80
ESTIMATED participants
Leadless Micra AV Transcatheter Pacing System
DEVICE
Transvenous Azure XT DR dual chamber pacemaker
DEVICE
Lead Sponsor
University of Aarhus
Collaborators
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06910059