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NCT Number: NCT07106788

Aveir Leadless Pacemaker Japan PMS

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.

Recruiting

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Key information

Conditions

Leadless Pacemaker

Sex eligibility

All sexes

Study type

Observational

Primary location

Nagoya University Hospital, Nagoya, Aichi-ken, Japan

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aveir DR Leadless Pacemaker Implant

Device

Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium

Single-chamber atrial Aveir patients

Device

Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium

Upgrades

Device

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.

Roll-over

Device

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.

Primary outcomes

  1. Primary Safety Endpoint

    Time frame: 36-month

    The primary safety endpoint of this PMS evaluates the 3-year Aveir DR LP system complication-free rate in de novo Aveir DR patients (primary analysis group).

    A complication is defined as a device-or-procedure-related serious adverse device effect (SADE), including those that prevent initial implantation (includes both Atrial LP and Ventricular LP related complications and implant procedure-related complications).

Other outcomes

  1. Key Survey Items - Descriptive Endpoints

    Time frame: 36-month

    The key survey item - descriptive endpoints are evaluated as rates for the following adverse events for all patients:

    • Atrial fibrillation
    • Dislodgement of atrial LP
    • Myocardial injury (defined as cardiac perforation, pericardial effusion, or cardiac tamponade)
    • Physical interference with other procedures or devices

    Additionally, the number of events of atrial LP removal and the success rate of removals will be reported.

Study contacts

Contact information is provided by the study sponsor or research team.

Mieko Otake

CONTACT

[email protected]

+81-80-5866-9006

Stephanie Delgado

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Abbott Medical Devices

Industry

Registry information

Official study title

Aveir Leadless Pacemaker Japan Post Marketing Surveillance

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Aug 6, 2025
Registry last updated
May 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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