Aveir Leadless Pacemaker Japan PMS
Recruiting
Observational Study
Leadless Pacemaker
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
No Study Drug
Researchers observe your health over time — no experimental treatment is given.
At a Glance
- Sex
- Any
- Study type
- Observational
- Participants needed
- 304 (estimated)
- Sponsor
- Abbott Medical Devices · Industry
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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-…
Trial Locations
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Eligibility Criteria
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 leadles…
Contacts