Leadless Pacemaker
Conditions
Keywords
leadless pacemaker, AVEIR
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.
Interventions
DEVICEAveir DR Leadless Pacemaker Implant
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
DEVICESingle-chamber atrial Aveir patients
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
DEVICEUpgrades
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.
DEVICERoll-over
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.
Sponsors
Abbott Medical Devices
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Japan
Contacts
CONTACTMieko Otake
CONTACTStephanie Delgado
Outcome results
None listed