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

The Amvia pacemaker family, has been CE approved in the European Union since
May 2023. This means that the Amvia pacemaker fulfils the European regulatory
requirements for medical device products and therefore can be used in patients
with a pacemaker indication (also outside clinical investigations). According
to the Medical Device Regulation (EU) 2017/745 (MDR, Article 61 §4 and ANNEX
XIV part B) a Post-Market Clinical FUP (PMCF) study is required as part of the
post-market clinical follow-up and surveillance activities to confirm the
safety and performance of the CE marked device throughout its expected
lifetime. Thus, this study intends to collect data which will be used for
regulatory purposes (MDR) in a post-market setting.

The aim of this study is to collect data to confirm clinical safety and
performance of the Amvia pacemaker family to fulfil the regulatory requirements
for products that are available on the market. The collected data may also be
used to support further product development.

An open-label, prospective, international, multicenter, non-randomized study.

Collection of safety and performance data during the implantation and follow-up
of an Amvia pacemaker. A strict follow-up schedule needs to be followed in
order to collect the necessary endpoint data from a device interrogation at the
2-, 6- and12-month follow-up after the implantation + usage of the BIOTRONIK
Home Monitoring system.

This study is classified as a PMCF without invasive and/or burdensome
procedures. As the implantation of the Amvia pacemaker thus not differ from the
standard implantation procedure of a pacemaker, no study specific risks are
associated with the implantation procedure. There are however possible risks
that we do not know about at the moment (residual risks), even in a post market
setting (after successful conformity assessment).
The timing of the study follow-up visits (2-, 6- & 12-month follow-up) might
differ from the standard routine in the participating hospitals. The duration
of the follow-up visits is increased compared to the routine follow-ups due to
the data collection for the study on the device measurements and features. The
usage of Home Monitoring is mandatory but this is not a burden for the subject
rather an advantage as it allows for the early detection of events as this is
in line with the current International Guidelines (already since 2015 the usage
of Home Monitoring is endorsed by the HRS guidelines: with a Class I (A)
recommendation that all patients with an Cardiac Implantable Electronic Device
should be offered Remote Monitoring as part of the standard FUP management).