BradycardiaNCT06854484
AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
An observational study of Bradycardia and Atrio-Ventricular Block, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
Trial summary
This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Atrio-Ventricular Block, Syncope
- What is being tested?
- AVEIR™leadless pacemaker
- Type of treatment
- Medical device
- How many people
- 300 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- 15 Apr 2025to Sep 2032
- How long will I take part?
- 5 Years
- 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: Consecutive cardiology patients listed for leadless pacemaker implantation and fitted with AVEIR™ LP device in the usual clinical practice in the UK National Health Service centres.
Who may be able to join
- Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).
Who cannot join
- Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
- Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom2 sites, 2 recruiting
- Recruiting
Royal Brompton Hospital
London, UK, SW3 6NP
Ines Kralj-Hans, PhD, 020 7352 8121, i.kralj-hans@nhs.net
Veronica Tudor, PhD, veronicaalina.tudor@nhs.net
- Not yet recruiting
The Royal Brompton Hospital
London
Ines Kralj-Hans, PhD, i.kralj-hans@rbht.nhs.uk
About this study
Official title: AVEIR™ Leadless Pacemaker United Kingdom Registry
This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.
Read the detailed description
AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.
The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.
Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.
- Conditions
- Bradycardia, Atrio-Ventricular Block, Syncope
- Being tested
- AVEIR™leadless pacemaker
- Keywords
- AVEIR leadless pacemaker
- Medical subject headings
- Bradycardia, Syncope
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVEIR™leadless pacemakerDevice
AVEIR™ leadless pacemaker implantation
| Study group | Role | What they receive |
|---|---|---|
| Patients requiring leadless pacemaker insertion | Patients who require leadless pacemaker to manage their heart condition Receives: Device: AVEIR™leadless pacemaker |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients without complications related to the device or implantation procedure.
Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation.
Measured: 5 years
Percentage of patients requiring re-intervention.
Replacement, explant, upgrade, or modification of the position of the device are considered re-interventions which will be used to evaluate safety of the device.
Measured: 5 years
Stimulation threshold (V) in the therapeutic zone
Minimum current needed to stimulate the paced chamber.
Measured: 5 years
Percentage of stimulation in the therapeutic zone
Percentage of paced vs non paced heart beats.
Measured: 5 years
Impedance (Ohm) of R waves in the therapeutic zone
Physiological measure recorded by the device.
Measured: 5 years
Amplitudes of R waves (mV) in the therapeutic zone
Physiological measure recorded by the device.
Measured: 5 years
Secondary outcomes (4)
Age of patient (years) at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Measured: 5 years
Sex of patient at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Measured: 5 years
Medical history at AVEIR ™ leadless pacemaker implantation
List of significant cardiac or other comorbidities at the time of pacemaker implantation to describe patient population receiving AVEIR ™ leadless pacemaker.
Measured: 5 years
Indications for AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
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 posted3 Mar 2025
- Study start15 Apr 2025
- Primary completionMar 2032 (estimated)
- Study completionSep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- 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
- Other
- Enrolment
- 300 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tom Wong, MD, Principal investigator, Royal Brompton and Harefield Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06854484
- Sponsor's protocol ID
- AVEIR™ Registry
- Other IDs
- Medical Affairs CR24562
- Status last verified
- Jul 2025
- First submitted
- 28 Jan 2025
- Last updated
- 29 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVEIR™ Leadless Pacemaker United Kingdom Registry
- ClinicalTrials.gov ID
- NCT06854484
- Acronym / sponsor ID
- AVEIR™ Registry
- Conditions
- Bradycardia, Atrio-Ventricular Block, Syncope
- Keywords
- AVEIR leadless pacemaker
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Royal Brompton & Harefield NHS Foundation TrustUniversity, hospital or other
- Study start
- 15 Apr 2025 (actual)
- Primary completion
- Mar 2032 (estimated)
- Study completion
- Sep 2032 (estimated)
- First posted
- 3 Mar 2025 (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.
This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation. The main goal is to evaluate the long term safety and efficacy of AVEIR™ leadless pacemaker device in the usual clinical settings within the UK National Health Service. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.
Detailed description
AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group.
The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK.
Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 5 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients requiring leadless pacemaker insertion | – | Device: AVEIR™leadless pacemakerPatients who require leadless pacemaker to manage their heart condition |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Consecutive cardiology patients listed for leadless pacemaker implantation and fitted with AVEIR™ LP device in the usual clinical practice in the UK National Health Service centres.
Key inclusion criteria (3 listed)
- Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing
- Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and
- Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written informed consent, approved by the Regional Ethics Committee (REC).
Key exclusion criteria (3 listed)
- Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist.
- Subject is not willing to comply with clinical investigation procedures and does not agree to return for all required follow-up visits, tests, and exams
- Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a signed written informed consent, approved by the REC
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™leadless pacemakerAVEIR™ leadless pacemaker implantation | Device | Patients requiring leadless pacemaker insertion |
Primary outcome
Percentage of patients without complications related to the device or implantation procedure.
Time frame: 5 years
Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation.
Percentage of patients requiring re-intervention.
Time frame: 5 years
Replacement, explant, upgrade, or modification of the position of the device are considered re-interventions which will be used to evaluate safety of the device.
Stimulation threshold (V) in the therapeutic zone
Time frame: 5 years
Minimum current needed to stimulate the paced chamber.
Percentage of stimulation in the therapeutic zone
Time frame: 5 years
Percentage of paced vs non paced heart beats.
Impedance (Ohm) of R waves in the therapeutic zone
Time frame: 5 years
Physiological measure recorded by the device.
Amplitudes of R waves (mV) in the therapeutic zone
Time frame: 5 years
Physiological measure recorded by the device.
4 secondary outcomes
Age of patient (years) at AVEIR ™ leadless pacemaker implantation
Time frame: 5 years
Sex of patient at AVEIR ™ leadless pacemaker implantation
Time frame: 5 years
Medical history at AVEIR ™ leadless pacemaker implantation
Time frame: 5 years
Indications for AVEIR ™ leadless pacemaker implantation
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 29 Jul 2025.
- 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.
Tom Wong, MD principal investigator
Royal Brompton and Harefield Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Atrio-Ventricular Block, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.
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 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: looking for participants now, as of the sponsor's last update on 29 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. 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 Ines Kralj-Hans, PhD (0330128 8854, i.kralj-hans@rbht.nhs.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients without complications related to the device or implantation procedure. (time frame: 5 years). The study lists 6 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 29 Jul 2025.