Aveir Leadless Pacemaker Japan PMS

NCT07106788 | Recruiting FDA Device

• 1 other identifier: CL1027565
• Study Type: observational
• Target: 304
• Locations: 1 country
• Sites: 9

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.

Conditions

Leadless Pacemaker

Keywords

leadless pacemaker; AVEIR

Outcome Measures

Primary Outcomes (1)

• Primary Safety Endpoint

  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).

  36-month

Other Outcomes (1)

• Key Survey Items - Descriptive Endpoints

  36-month

Study Arms (4)

Primary Analysis Cohort

This survey targets the registration of 194 patients indicated for de novo dual-chamber LP's. All de novo patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up

Device: Aveir DR Leadless Pacemaker Implant

Single-chamber atrial Aveir patients

Up to 50 patients indicated for a de novo atrial LP may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up

Device: Single-chamber atrial Aveir patients

Upgrade Patients

Up to 36 upgrade patients (existing ventricular LP to dual-chamber LP system or existing atrial LP to dual-chamber LP system) may be registered during the primary de novo dual-chamber LP registration period. Data will be analyzed separately, and the patients will be followed until the last de novo dual-chamber patient (primary analysis cohort) reaches 3 years of follow-up

Device: Upgrades

Rollover

All patients from Japan sites with existing active Aveir LPs from the Aveir DR IDE i2i Study (up to 24 patients) are eligible to roll over into the Aveir Japan PMS upon consent for ongoing follow-up. Data from the rollover patients will be summarized separately. Rollover patients will be followed until the last de novo dual-chamber patient (Aveir Japan PMS primary analysis cohort) reaches 3 years of follow-up

Device: Roll-over

Interventions

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

Primary Analysis Cohort

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

Single-chamber atrial Aveir patients

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.

Upgrade Patients

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.

Rollover

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The Surveillance will register patients who are indicated for dual-chamber leadless pacemaker, single-chamber atrial leadless pacemaker, roll-over patients with existing Aveir DR leadless pacemaker system from the Aveir DR i2i IDE study, and upgrade patients with existing single-chamber Aveir leadless pacemaker that require an upgrade to a dual-chamber Aveir leadless pacemaker system.

You may qualify if:

• 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

You may not qualify if:

• N/A

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (9)

Kokura Memorial Hospital

Kitakyushu, Fukuoka, 802-8555, Japan

RECRUITING

St. Marianna University School of Medicine Hospital

Kawasaki, Kanagwa, 2168511, Japan

RECRUITING

Sendai Kousei Hospital

Sendai, Miyagi, 981-0914, Japan

RECRUITING

Kurashiki Central Hospital

Kurashiki, Okayama-ken, 710-0052, Japan

RECRUITING

Osaka Keisatsu Hospital

Osaka, Osaka, 543-8922, Japan

RECRUITING

National Cerebral & Cardiovascular Center Hospital

Suita, Osaka, 564-8565, Japan

RECRUITING

Juntendo University Shizuoka Hospital

Izunokuni, Shizuok, 410-2295, Japan

RECRUITING

Tokyo Medical University Hospital

Tokyo, Tokyo, 160-0023, Japan

RECRUITING

Tokyo Women's Hospital

Tokyo, Tokyo, 162-8666, Japan

RECRUITING

Central Study Contacts

Mieko Otake

CONTACT

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

Stephanie Delgado

CONTACT

stephanie.delgado1@abbott.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 30, 2025
• First Posted: August 6, 2025
• Study Start: May 26, 2025
• Primary Completion (Estimated): November 1, 2029
• Study Completion (Estimated): November 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: IPD will be available following publication of primary results for 25 years following study completion date.
• Access Criteria: Proposals for requesting individual data may be submitted to the Sponsor at AveirDR\ IDE@abbott.com.

Locations

JP (9)