Aveir Leadless Pacemaker Japan PMS

Recruiting

• Conditions: Leadless Pacemaker

• Registration Number: NCT07106788
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2025-05-26
• Status Verified: 2025-07
• Study First Submitted: 2025-07-30
• Study First Submitted QC: 2025-07-30
• Last Update Submitted: 2025-07-30
• Study First Posted: 2025-08-06
• Last Update Posted: 2025-08-06
• Primary Completion: 2029-11
• Study Completion: 2029-11-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 304

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary Safety Endpoint	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).

Trial Locations

Locations (4)

Kokura Memorial Hospital; 🇯🇵 Kitakyushu, Fukuoka, Japan

Kurashiki Central Hospital; 🇯🇵 Kurashiki, Okayama, Japan

National Cerebral & Cardiovascular Center Hospital; 🇯🇵 Suita, Osaka, Japan

Tokyo Women's Hospital; 🇯🇵 Tokyo, Japan