AVEIR leadless pacemaker registry in the United Kingdom
AVEIR™ Leadless Pacemaker United Kingdom Registry
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust Academic / other |
| Locations | 2 sites (London, UK and 1 other locations) |
| Trial ID | NCT06854484 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: Other leadless pacemaker programs have shown favorable safety and performance in real-world registries, but long-term AVEIR-specific data remain limited.
Eligibility criteria
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 this trial is running
London, UK and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.