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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
80
Patients are implanted with a leadless Micra AV TPS
Patients are implanted with a transvenous Azure XT DR pacemaker
Department of Cardiology Aarhus University Hospital
Aarhus, Region Midt, Denmark
RECRUITINGDepartment of Cardiology Odense University Hospital
Odense, Region Syd, Denmark
RECRUITINGQuality of Life by SF36
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.
Time frame: 7 months
Patient Acceptance by FPAS
Self-reported patient acceptance as measured by Florida Patient Acceptance Scale. The scale ranges from 0-100. 0 denotes minimal device acceptance and 100 denotes maximal device acceptance.
Time frame: 7 months
Exercise capacity by 6MWT
Exercise capacity as measured by 6-minute walk test
Time frame: 7 months
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