Danish Randomized Trial on Leadless vs Transvenous Pacing

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.

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