This is a prospective, randomized controlled (1:1) multicenter trial. The pilot study will be conducted up to three clinical sites in the United States. The primary purpose of this study is to compare the overall safety and efficacy between the leadless pacemaker and left bundle area pacing.
Age > 18
permanent pacemaker implantation for AV node disease (first, second or third degree), OR
post-TAVR patient requiring permanent pacemaker implantation
Preserved ejection fraction > 50%
Sinus node dysfunction, anticipating atrial pacing or persistent atrial fibrillation
Anatomical restriction for either MICRA or transvenous pacing such as
Access vein occlusion or thrombosis
previous radiation therapy at insertion site
NCH Healthcare System, Inc. dba Naples Comprehensive Health and dba NCH
Lead sponsor
Medtronic
Collaborator