Menu
Recruiting NCT07106788

Aveir Leadless Pacemaker Japan PMS

— Observational Leadless Pacemaker

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aveir DR Leadless Pacemaker Implant, Single-chamber atrial Aveir patients, Upgrades, Roll-over.
Who it may be relevant to
Registry conditions: Leadless Pacemaker. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Aveir Leadless Pacemaker Japan Post Marketing Surveillance

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.

Interventions

  • 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.

Primary outcome measures

  • Primary Safety Endpoint [Time frame: 36-month]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 14 centers
  • Nagoya University Hospital — Nagoya
  • Kokura Memorial Hospital — Kitakyushu
  • St. Marianna University School of Medicine Hospital — Kawasaki
  • Sendai Kousei Hospital — Sendai
  • Kurashiki Central Hospital — Kurashiki
  • Kansai Medical University Hospital — Hirakata
  • Osaka Keisatsu Hospital — Osaka
  • National Cerebral & Cardiovascular Center Hospital — Suita
  • … and 6 more centers

Identifiers

NCT: NCT07106788 · CL1027565

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗