Overview
The primary purpose of the PMS is to collect safety information on the Aveir DR leadless cardiac pacemaker (LP) system in a population indicated for de novo dual-chamber pacing. Additionally, the PMS will collect data on rollover patients from the Aveir DR i2i IDE, Aveir AR LP in patients indicated for single-chamber pacing in the right atrium, and upgradeability in patients implanted with single-chamber Aveir atrial or ventricular LP that require an upgrade to a dual-chamber Aveir LP.
Eligibility
Inclusion Criteria:
- Patient is indicated for dual-chamber or single-chamber atrial leadless pacemaker system
- Patient is a roll-over patient with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study
- Patient is an upgrade patient with existing single-chamber Aveir leadless pacemaker that requires an upgrade to a dual-chamber Aveir leadless pacemaker system
Exclusion Criteria:
- N/A