Cardiac PacemakerNCT06542133
AVEIR Remote Care System Non-Significant Risk Study
An observational study of Cardiac Pacemaker and Cardiac Rhythm Disorder, run by Abbott Medical Devices at 3 sites in United States.
Trial summary
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- What is being tested?
- AVEIR remote care system
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 3 sitesUnited States
- Study dates
- 10 Jun 2024to 30 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Primary care clinic
Who may be able to join
- Subject must provide written informed consent prior to any study-related procedure.
- Subject is willing and has consented to study clinical procedure.
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
- Subject has an active, appropriately functioning Aveir leadless pacemaker system
- Subject is willing to use the device
Who cannot join
- Subject is unable to read/write at a sufficient level to provide informed consent.
- Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
- Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Arrhythmia Research Group
Jonesboro, Arkansas, 72401
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Premier Cardiology, Inc
Newport Beach, California, 92663
About this study
Official title: AVEIR Remote Care System Data Collection Non-Significant Risk Study
The goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.
Read the detailed description
To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Being tested
- AVEIR remote care system
- 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 remote care systemDevice
In-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients
| Study group | Role | What they receive |
|---|---|---|
| Observational, Single Arm, Non Randomized | Aveir leadless pacemaker system patients Receives: Device: AVEIR remote care system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful end-to-end transmission performance metrics
Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care.
Measured: The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2024
- Study start10 Jun 2024
- Primary completion12 Jul 2024
- Study completion30 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 only
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06542133
- Sponsor's protocol ID
- ABT-CIP-10527
- Status last verified
- Apr 2025
- First submitted
- 18 Jul 2024
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Sundaram S, Chellappa N, Chaniary K, Lo M, Nair D, Banker R. Remote monitoring of leadless pacemakers using a novel conductive telemetry communication method. J Interv Card Electrophysiol. 2025 Jul 22. doi: 10.1007/s10840-025-02095-8. Online ahead of print.
PubMed 40694240
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVEIR Remote Care System Data Collection Non-Significant Risk Study
- ClinicalTrials.gov ID
- NCT06542133
- Acronym / sponsor ID
- ABT-CIP-10527
- Conditions
- Cardiac Pacemaker, Cardiac Rhythm Disorder, Bradycardia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- 12 Jul 2024 (actual)
- Study completion
- 30 Aug 2024 (actual)
- First posted
- 7 Aug 2024 (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 goal of the study is to understand the performance of the AVEIR Remote Care System in an initial patient cohort which will inform the ability to offer a remote follow-up solution to all patients implanted with Aveir LP devices.
Detailed description
To collect acute performance data about the AVEIR Remote Care System in participants implanted with a compatible dual or single chamber Aveir Leadless Pacemaker System by participants completing remote transmissions with the system
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational, Single Arm, Non Randomized | – | Device: AVEIR remote care systemAveir leadless pacemaker system patients |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Primary care clinic
Key inclusion criteria (5 listed)
- Subject must provide written informed consent prior to any study-related procedure.
- Subject is willing and has consented to study clinical procedure.
- Subject is ≥ 18 years of age or age of legal consent, whichever age is greater
- Subject has an active, appropriately functioning Aveir leadless pacemaker system
- Subject is willing to use the device
Key exclusion criteria (3 listed)
- Subject is unable to read/write at a sufficient level to provide informed consent.
- Subject is unable to make the decision to participate in a clinical investigation on their own or are unable to fully understand all aspects of the investigation that are relevant to the decision to participate.
- Subject has presence of medical, social, or psychological conditions that, in the investigator's opinion, could confound the study, limit the subject's ability to participate in the clinical investigation .
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 remote care systemIn-clinic or an at-home system designed to support remote follow up in Aveir leadless pacemaker patients | Device | Observational, Single Arm, Non Randomized |
Primary outcome
Successful end-to-end transmission performance metrics
Time frame: The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)
Successful transmission performance metrics of the AVEIR Remote Care System in approximately 32 subjects who have received an Aveir LP implanted system as part of their standard of care.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Derived from this study: PubMed 40694240Sundaram S, Chellappa N, Chaniary K, Lo M, Nair D, Banker R. Remote monitoring of leadless pacemakers using a novel conductive telemetry communication method. J Interv Card Electrophysiol. 2025 Jul 22. doi: 10.1007/s10840-025-02095-8. Online ahead of print.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
3 sites 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 Cardiac Rhythm Disorder, run by Abbott Medical Devices at 3 sites 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 5 inclusion and 3 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: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Successful end-to-end transmission performance metrics (time frame: The expected duration of each subject's participation is approximately 30 minutes for an in-clinic visit to complete two transmissions and thereafter an optional at-home transmission (expected duration 10-15 minutes)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06542133, which also lists 1 linked publication.
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 10 Apr 2025.