Cardiac PacemakerNCT05270499
Aveir VR Real-World Evidence Post-Approval Study
An observational study of Cardiac Pacemaker and Arrythmia, run by Abbott Medical Devices at 1 site in United States.
Trial summary
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Pacemaker, Arrythmia, Bradycardia
- What is being tested?
- Aveir VR Leadless Pacemaker System
- Type of treatment
- Medical device
- How many people
- 3,427 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 30 Sep 2034
- How long will I take part?
- 10 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients who had an implant of the Aveir VR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis
Eligibility Criteria:
- Implanted with an Aveir VR leadless pacemaker
- Continuous enrollment in Medicare Part A and Part B for 12 months prior to implant and for 30 days after implant, except in the case of death within the 30-day period
- Ability to link with Medicare fee-for-service data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aveir Single-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
The purpose of this post-approval study is to evaluate the long-term safety of the single-chamber Aveir VR leadless pacemaker using real-world evidence methods.
Read the detailed description
This is a non-randomized, multi-center study leveraging real-world evidence methods that merge multiple real-world datasets from Abbott and the Center for Medicare Services to assess Aveir VR leadless pacemaker safety in a large patient population. The results from this study will data to fulfill the Condition of Approval requirements for the Aveir VR device from FDA.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Being tested
- Aveir VR Leadless Pacemaker System
- Keywords
- bradycardia, sick sinus rhythm, pacemaker, av block, Vasovagal Syncope
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia, Atrioventricular Block, Syncope, Vasovagal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aveir VR Leadless Pacemaker SystemDevice
This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention will be conducted in this study.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Non randomized Receives: Device: Aveir VR Leadless Pacemaker System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects Free from Acute Aveir VR System-Related Complications
Freedom from complications through 30 days post implant procedure
Measured: 30 days
Number of Subjects Free from Chronic Aveir VR System-Related Complications
Freedom from Complications from 31 days through 10 years post implant procedure procedure
Measured: 10 Years
Secondary outcomes (2)
Number of Subjects Free from Individual Aveir VR Leadless Pacemaker-Related Complications
Complication rate of the Aveir VR leadless pacemaker for individual acute and chronic complications
Measured: 10 Years
Number of Subjects with End of Device Service Events
Care of subjects at the end of device service. End-of-device service is defined as any event prior to the 10-year follow-up period which results in the leadless pacemaker being explanted or deactivated, another CIED implanted, or death. All instances of the end-of-service will be summarized by event type and time to event.
Measured: 10 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2022
- Study start21 Jun 2022
- Primary completion30 Sep 2034 (estimated)
- Study completion30 Sep 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac PacemakerStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,427 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicole Harbert, Study director, Abbott
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05270499
- Sponsor's protocol ID
- ABT-CIP-10418
- Status last verified
- May 2026
- First submitted
- 28 Feb 2022
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No