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Aveir Leadless Pacemaker Japan PMS

Aveir Leadless Pacemaker Japan PMS

Recruiting
All
Phase N/A

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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

Study details
    Leadless Pacemaker

NCT07106788

Abbott Medical Devices

9 August 2025

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