Aveir Leadless Pacemaker Japan PMS

ConditionLeadless Pacemaker

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

AgeNot listed

SponsorAbbott Medical Devices

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

N/A

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

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
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
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.
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.

Treatment groups

304 Participants

are divided into 4 treatment groups

Group A: Primary Analysis Cohort1 intervention

Group B: Single-chamber atrial Aveir patients1 intervention

Group C: Upgrade Patients1 intervention

Group D: Rollover1 intervention

Trial outcomes

Primary outcomes

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).

Time frame

36-month

Other outcomes

Key Survey Items - Descriptive Endpoints

The key survey item - descriptive endpoints are evaluated as rates for the following adverse events for all patients: * Atrial fibrillation * Dislodgement of atrial LP * Myocardial injury (defined as cardiac perforation, pericardial effusion, or cardiac tamponade) * Physical interference with other procedures or devices Additionally, the number of events of atrial LP removal and the success rate of removals will be reported.

Time frame

36-month

Locations14

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Sponsors and contacts

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Abbott Medical Devices

Lead sponsor

Source ClinicalTrials.gov

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