Cardiac PacemakerNCT05935007
Aveir DR 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 dual-chamber Aveir DR 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 DR Leadless Pacemaker System
- Type of treatment
- Medical device
- How many people
- 1,805 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2023to 31 Dec 2030
- 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: All patients who had an implant of the Aveir DR 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 DR 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. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Abbott
Sylmar, California, 91342
Nicole Harbert, 972-526-4841, Nicole.Harbert@abbott.com
About this study
Official title: Aveir Dual-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 dual-chamber Aveir DR 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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.
Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Being tested
- Aveir DR 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 DR Leadless Pacemaker SystemDevice
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study.
| Study group | Role | What they receive |
|---|---|---|
| Interventions | Device: Aveir DR Leadless Pacemaker System
This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study. Receives: Device: Aveir DR 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 DR System-Related Complications
Freedom from key acute complications through 30 days post implant procedure
Measured: 30 Days
Number of Subjects Free from Chronic Aveir DR System-Related Complications
Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure
Measured: 5 Years
Secondary outcomes (2)
Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related
Complication rate of the Aveir DR leadless pacemaker for key individual acute and chronic complications
Measured: 5 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 5-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: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2023
- Study start31 Oct 2023
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Dec 2030 (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
- 1,805 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
- NCT05935007
- Sponsor's protocol ID
- ABT-CIP-10454
- Status last verified
- May 2026
- First submitted
- 24 May 2023
- Last updated
- 20 May 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aveir Dual-Chamber Leadless Pacemaker Real-World Evidence Post-Approval Study
- ClinicalTrials.gov ID
- NCT05935007
- Acronym / sponsor ID
- ABT-CIP-10454
- Conditions
- Cardiac Pacemaker, Arrythmia, Bradycardia
- Keywords
- bradycardia, sick sinus rhythm, pacemaker, av block, vasovagal syncope
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,805 participants (estimated)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2023 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Dec 2030 (estimated)
- First posted
- 7 Jul 2023 (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 post-approval study is to evaluate the long-term safety of the dual-chamber Aveir DR leadless pacemaker using real-world evidence methods.
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 DR leadless pacemaker safety in a large patient population. The results from this study will provide long-term safety data for the Aveir dual chamber LP and the Aveir atrial LP to fulfill the Condition of Approval requirements for the Aveir DR device from FDA.
Due to the RWE data collection methods used in this study, a central IRB approved informed consent waiver has been granted. Due to this waiver and the sponsor's use of the central IRB, individual hospitals are not required to consent patients or complete local IRB submissions for this RWE study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventions | – | Device: Aveir DR Leadless Pacemaker SystemDevice: Aveir DR Leadless Pacemaker System This study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who had an implant of the Aveir DR device, meet inclusion/exclusion criteria, link to Medicare FFS claims, and survive past 30 days will be included in the analysis
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 DR Leadless Pacemaker SystemThis study will utilize real-world data from patients implanted with the Aveir DR Leadless Pacemaker System. No device intervention will be conducted in this study. | Device | Interventions |
Primary outcome
Number of Subjects Free from Acute Aveir DR System-Related Complications
Time frame: 30 Days
Freedom from key acute complications through 30 days post implant procedure
Number of Subjects Free from Chronic Aveir DR System-Related Complications
Time frame: 5 Years
Freedom from key chronic complications from 31 days through 5 years post implant procedure procedure
2 secondary outcomes
Number of Subjects Free from Individual Aveir DR Leadless Pacemaker-Related
Time frame: 5 Years
Number of Subjects with End of Device Service Events
Time frame: 5 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 20 May 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.
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?
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: looking for participants now, as of the sponsor's last update on 20 May 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?
Contact Nicole Harbert (972-526-4841, nicole.harbert@abbott.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Subjects Free from Acute Aveir DR System-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 20 May 2026.