BIO|CONCEPT.Amvia Study

The goal of this exploratory study is to test the preliminary safety and product performance of the new Amvia/Solvia pacemaker family in subjects that require a pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation. The study will be conducted at sites in Australia and New Zealand. It is planned to include 50 subjects in the study. Participants will visit sites at enrollment in the study, at implantation, pre-hospital discharge, 1- 3- and 12-month follow-up visits. At the visits the device will be interrogated and standard device measurements including those related to special features will be performed to assess the functionality of the device. Programming of the pacemakers will be done according to the participant´s therapeutical needs.

Inclusion Criteria:Standard indication for pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation, including de novo, upgrade or replacement implantationsAbility to understand the nature of the studyWillingness to provide written informed consentAbility and willingness to perform all follow-up visits at the study siteAbility and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring conceptExclusion Criteria:Planned for conduction system pacingPlanned for activation of atrial anti-tachycardia pacing (aATP) without known history of atrial arrhythmia, or with permanent atrial fibrillation (AF)Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 monthsPregnant or breast feedingAge less than 18 yearsParticipation in another interventional clinical investigation according to the definition given in the study protocolLife-expectancy less than 12 months