Cardiac PacemakerCEDNCT05336877
Aveir VR Coverage With Evidence Development 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 coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP). 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 and Single-Chamber Transvenous Pacemaker
- Type of treatment
- Medical device
- How many people
- 8,744 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Jun 2022to 1 Jan 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location
Who may be able to join
- Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
- OR
- Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
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 compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.
The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Being tested
- Aveir VR Leadless Pacemaker System, Single-Chamber Transvenous Pacemaker
- Medical subject headings
- Arrhythmias, Cardiac, Bradycardia
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 is required in this study.
Single-Chamber Transvenous PacemakerDevice
This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study.
| Study group | Role | What they receive |
|---|---|---|
| Device: Aveir VR Leadless Pacemaker System | This study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study. Receives: Device: Aveir VR Leadless Pacemaker System | |
| Device: Single-Chamber Transvenous Pacemaker | This study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study. Receives: Device: Single-Chamber Transvenous Pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects with Acute Device-Related Complications
Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.
Measured: 30 days
Number of Subjects Alive after 2 Years
The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.
Measured: 2 years
Secondary outcomes (2)
Number of Subjects with Chronic Device-Related Complications
Rate of chronic complications in subjects implanted with Aveir VR LP compared with subjects implanted with a single-chamber ventricular transvenous pacemaker, from 31 days through six months post implant procedure. A chronic complication is defined as a post-procedural, device-related adverse event that requires invasive intervention to resolve.
Measured: 6 months
Number of Subjects with a Device-Related Re-Intervention
Rate of device-related re-intervention in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker, through 2 years post implant procedure.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2022
- Study start21 Jun 2022
- Primary completion1 Jan 2028 (estimated)
- Study completion1 Jan 2028 (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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 8,744 participants (estimated)
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
- NCT05336877
- Sponsor's protocol ID
- ABT-CIP-10426
- Acronym
- CED
- Status last verified
- Oct 2026
- First submitted
- 11 Apr 2022
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aveir Single-Chamber Leadless Pacemaker Coverage With Evidence Development (ACED) Post-Approval Study
- ClinicalTrials.gov ID
- NCT05336877
- Acronym / sponsor ID
- CED / ABT-CIP-10426
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 8,744 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 1 Jan 2028 (estimated)
- First posted
- 20 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this coverage with evidence development (CED) study is to evaluate complications and long-term health outcomes of the single-chamber Aveir Single-Chamber Leadless Pacemaker device (Aveir VR LP).
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 compare Aveir VR LP safety and health outcomes to those in patients implanted with single-chamber transvenous pacemakers in a large patient population.
The study will enroll all Medicare patients implanted with the Aveir VR LP and, as the control group, patients implanted with a single-chamber ventricular transvenous pacemaker from any manufacturer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Device: Aveir VR Leadless Pacemaker System | – | Device: Aveir VR Leadless Pacemaker SystemThis study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study. |
| Device: Single-Chamber Transvenous Pacemaker | – | Device: Single-Chamber Transvenous PacemakerThis study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study cohort will include all Medicare patients with continuous claims data implanted with an Aveir VR leadless pacemaker or a full-system single-chamber ventricular transvenous pacemaker (from any manufacturer) in any US location
Key inclusion criteria (3 listed)
- Medicare beneficiaries implanted with an Aveir VR leadless pacemaker on or after the study start date (i.e., the date of Aveir VR market approval) will be included in the study.
- OR
- Medicare beneficiaries implanted with a full system (e.g. lead and generator) single-chamber ventricular transvenous pacemaker on or after the study start date
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aveir VR Leadless Pacemaker SystemThis study will utilize real-world data from patients implanted with the Aveir VR Leadless Pacemaker System. No device intervention is required in this study. | Device | Device: Aveir VR Leadless Pacemaker System |
| Single-Chamber Transvenous PacemakerThis study will utilize real-world data from patients implanted with a single-chamber transvenous pacemaker as a comparator to the Aveir VR LP system study arm. No device intervention is required in this study. | Device | Device: Single-Chamber Transvenous Pacemaker |
Primary outcome
Number of Subjects with Acute Device-Related Complications
Time frame: 30 days
Rate of acute complications in subjects implanted with an Aveir VR LP compared to subjects implanted with a single-chamber ventricular transvenous pacemaker. Acute complications are defined as a peri-procedural, device-related adverse event within 30 days post-implant.
Number of Subjects Alive after 2 Years
Time frame: 2 years
The 2-year survival rate of subjects implanted with an Aveir VR LP compared with subjects implanted with single-chamber ventricular transvenous pacemaker.
2 secondary outcomes
Number of Subjects with Chronic Device-Related Complications
Time frame: 6 months
Number of Subjects with a Device-Related Re-Intervention
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nicole Harbert study director
Abbott
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Pacemaker and Arrythmia, run by Abbott Medical Devices at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects with Acute Device-Related Complications (time frame: 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.