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Recruiting NCT07106788

Aveir Leadless Pacemaker Japan PMS

Trial Parameters

Condition Leadless Pacemaker
Sponsor Abbott Medical Devices
Study Type OBSERVATIONAL
Phase N/A
Enrollment 304
Sex ALL
Min Age N/A
Max Age N/A
Start Date 2025-05-26
Completion 2029-11
Interventions
Aveir DR Leadless Pacemaker ImplantSingle-chamber atrial Aveir patientsUpgrades

Brief Summary

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 Criteria

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

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