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
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 design
Treatments tested in this trial
- Aveir DR Leadless Pacemaker Implant
- Single-chamber atrial Aveir patients
- Upgrades
- Roll-over
Treatment groups
304 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov