Danish Randomized Trial on Leadless vs Transvenous Pacing (DANVERS)
AV Block
About this trial
This is an interventional treatment trial for AV Block focused on measuring Leadless Pacing, Cardiac Pacemaker, Cardiac Arrythmia, Heart Disease
Eligibility Criteria
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
Sites / Locations
- Department of Cardiology Aarhus University HospitalRecruiting
- Department of Cardiology Odense University Hospital
Arms of the Study
Arm 1
Arm 2
Active Comparator
Active Comparator
Leadless Pacemaker
Transvenous pacemaker
Implantation with a leadless pacemaker
Implantation with a transvenous pacemaker