Loading clinical trials...

RECRUITING

Aveir Leadless Pacemaker Japan PMS

Aveir Leadless Pacemaker Japan Post Marketing Surveillance

NCT07106788•Abbott Medical Devices

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

Age

All ages

Sex

ALL

Healthy Volunteers

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

Locations (9)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, Japan

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagwa, Japan

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Kurashiki Central Hospital

Kurashiki, Okayama-ken, Japan

Osaka Keisatsu Hospital

Osaka, Osaka, Japan

National Cerebral & Cardiovascular Center Hospital

Suita, Osaka, Japan

Juntendo University Shizuoka Hospital

Izunokuni, Shizuok, Japan

Tokyo Medical University Hospital

Tokyo, Tokyo, Japan

Tokyo Women's Hospital

Tokyo, Tokyo, Japan

Key Dates

Start Date

May 26, 2025

Primary Completion Date

November 1, 2029

Completion Date

November 1, 2029

Last Updated

August 28, 2025

Enrollment

304

ESTIMATED participants

Conditions

Leadless Pacemaker

Interventions

Aveir DR Leadless Pacemaker Implant

DEVICE

Single-chamber atrial Aveir patients

DEVICE

Upgrades

DEVICE

Roll-over

DEVICE

Contacts

Mieko Otake

CONTACT

+81-80-5866-9006 mieko.otake@abbott.com

Stephanie Delgado

CONTACT

stephanie.delgado1@abbott.com

Leadless Pacemaker Implantation Positions and Its Relationship with Procedure Efficacy and Complication

NCT06692218

Leadless Pacemaker

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: August 28, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions