NCT07106788

Aveir Leadless Pacemaker Japan PMS

Aveir Leadless Pacemaker Japan Post Marketing Surveillance

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 304 (estimated)
• Sponsor: Abbott Medical Devices · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Leadless Pacemaker

Interventions

Type	Name	Description
DEVICE	Aveir DR Leadless Pacemaker Implant	Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
DEVICE	Single-chamber atrial Aveir patients	Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
DEVICE	Upgrades	Patients with an existing single-chamber leadless pacemaker will undergo a leadless pacemaker system implant wherein an additional leadless pacemaker will be implanted in either the right ventricle or right atrium to form a dual-chamber LP system.
DEVICE	Roll-over	Patients with an existing active Aveir DR leadless pacemaker system are eligible to be rolled into the Aveir Japan PMS upon consent for ongoing follow-up.

Timeline

• Start date: 2025-05-26
• Primary completion: 2029-11-01
• Completion: 2029-11-01
• First posted: 2025-08-06
• Last updated: 2025-08-28

Locations

9 sites across 1 country: Japan

Regulatory

• FDA-regulated device study