Aveir Leadless Pacemaker Japan PMS

Abbott

Status: Enrolling

Conditions: Leadless Pacemaker

Treatments: Device: Upgrades; Device: Aveir DR Leadless Pacemaker Implant; Device: Roll-over; Device: Single-chamber atrial Aveir patients

Study type: Observational

Funder types: Industry

Identifiers

NCT07106788

CL1027565

Details and patient eligibility

About

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.

Enrollment: 304 estimated patients

Sex: All

Volunteers: No 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

Trial design

304 participants in 4 patient groups

Primary Analysis Cohort

Description:

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

Treatment:

Device: Aveir DR Leadless Pacemaker Implant

Single-chamber atrial Aveir patients

Description:

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

Treatment:

Device: Single-chamber atrial Aveir patients

Upgrade Patients

Description:

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

Treatment:

Device: Upgrades

Rollover

Description:

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

Treatment:

Device: Roll-over