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.
Study Type
OBSERVATIONAL
Enrollment
304
Patients will undergo a dual chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right ventricle and right atrium
Patients will undergo a single chamber leadless pacemaker system implant wherein a leadless pacemaker will be implanted in the right atrium
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.
Nagoya University Hospital
Nagoya, Aichi-ken, Japan
RECRUITINGKokura Memorial Hospital
Kitakyushu, Fukuoka, Japan
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
St. Marianna University School of Medicine Hospital
Kawasaki, Kanagwa, Japan
RECRUITINGSendai Kousei Hospital
Sendai, Miyagi, Japan
RECRUITINGKurashiki Central Hospital
Kurashiki, Okayama-ken, Japan
RECRUITINGKansai Medical University Hospital
Hirakata, Osaka, Japan
RECRUITINGOsaka Keisatsu Hospital
Osaka, Osaka, Japan
RECRUITINGNational Cerebral & Cardiovascular Center Hospital
Suita, Osaka, Japan
RECRUITINGJuntendo University Shizuoka Hospital
Izunokuni, Shizuok, Japan
RECRUITINGToho University - Omori Medical Center
Ōta-ku, Tokyo, Japan
RECRUITING...and 4 more locations