AVEIR leadless pacemaker registry in the United Kingdom
Official title: AVEIR™ Leadless Pacemaker United Kingdom Registry
Run by Royal Brompton & Harefield NHS Foundation Trust · NCT06854484 · Data updated 2026-11-12
This project will follow people in the UK who receive an AVEIR leadless pacemaker to see how well the device works and how safe it is over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 2 sites (London, UK and 1 other locations) |
| Status | Recruiting |
| Started | April 15, 2025 |
| Main results expected | March 2032 |
| Study ends | September 2032 |
| Registry record updated | July 29, 2025 |
| Trial ID | NCT06854484 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults in the UK who are intended to receive or have received an AVEIR leadless pacemaker, can provide informed consent, and can attend routine follow-up visits at participating NHS centres are eligible.
✕Probably not a fit
Patients judged unsuitable for leadless implantation by their cardiologist, those unable or unwilling to comply with follow-up, or those who require pacing therapies not provided by a single‑chamber leadless device are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is an observational registry that will enroll up to 600 patients implanted with the AVEIR leadless pacemaker at approved NHS centres across the UK and follow them for five years. Investigators will collect anonymous clinical data including age, sex, medical history, indications for pacing, procedural details, and any device- or procedure-related complications. The device is delivered percutaneously via the femoral vein and provides single‑chamber bradycardia pacing with built-in sensing and battery. Patients will be followed according to routine NHS care with data entered into a central registry to characterize real-world performance and safety.
Why it matters
Potential benefit: If successful, the registry could confirm the long-term safety and performance of the AVEIR leadless pacemaker and give clinicians and patients greater confidence in choosing a leadless pacing option.
How similar studies have gone: Other leadless pacemaker programs have shown favorable safety and performance in real-world registries, but long-term AVEIR-specific data remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patient is intended to receive or was treated with a (AVEIR™) Leadless Transcatheter Pacing 2. Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams; and 3. 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). Exclusion Criteria: 1. Subject is not suitable for implantation of the leadless device according to the expert opinion of their cardiologist. 2. 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 3. 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
Where it's running
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Royal Brompton Hospital
London, UK, United Kingdom Recruiting -
The Royal Brompton Hospital
London, United Kingdom Not yet recruiting
Study contacts
- Principal investigator: Tom Wong, MD — Royal Brompton and Harefield Hospital
- Study coordinator: Ines Kralj-Hans, PhD
- Email: i.kralj-hans@rbht.nhs.uk
- Phone: 0330128 8854
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Cardioneuroablation for treating bradycardia
This study is testing a new procedure called cardioneuroablation to see if it can help people with slow heart rates feel better without needing a permanent pacemaker.
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Comparing cardioneuroablation and permanent pacing for treating bradycardia symptoms.
This study is testing if a new treatment called cardioneuroablation can help people with slow heart rates feel better and possibly stop using their pacemakers.
-
Observing patients with BIOTRONIK Implantable Cardiac Monitors
This study looks at how well the BIOMONITOR III and similar heart monitors work and keep patients safe over time.
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Registry for implantable cardiac devices
This study is tracking how well pacemakers and defibrillators work for people with heart rhythm problems to see if they can improve patient care and outcomes.
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This study tests whether doing a full-body ultrasound at the bedside changes how doctors manage older adults (65+) who come to the emergency department after a fall.
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SPIKE FLOW endocardial pacing lead safety and performance study
This study tests whether the SPIKE FLOW temporary endocardial pacing lead is safe and effective in adults needing temporary pacing during heart-related conditions.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.