Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

BIO|MASTER.Amvia: Post Market Clinical Follow-up Study for the Amvia/Solvia Pacemaker Family

The study is designed as an open-label, prospective, international, multicenter, non-randomized study to determine safety and product performance of the CE-marked Amvia/Solvia pacemaker family, including the aATP, CRT AutoAdapt and Early Check features in the setting of a post-market clinical follow-up study.

Inclusion Criteria:

• Standard indication for de novo, upgrade or replacement pacemaker or cardiac resynchronization therapy pacemaker (CRT-P) implantation
• Ability to understand the nature of the study
• Willingness to provide written informed consent
• Ability and willingness to perform all follow-up visits at the study site
• Ability and willingness to use the CardioMessenger and acceptance of the BIOTRONIK Home Monitoring® concept

Exclusion Criteria:

• Planned for conduction system pacing
• Planned cardiac surgical procedures or interventional measures other than the study procedure within the next 12 months
• Known pregnancy or breast feeding
• Age less than 18 years
• Participation in another interventional clinical investigation
• Life-expectancy less than 12 months