NCT06854484 AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
| NCT ID | NCT06854484 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal Brompton & Harefield NHS Foundation Trust |
| Condition | Bradycardia |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2025-04-15 |
| Primary Completion | 2032-03 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2025-04-15 with a primary completion date of 2032-03.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. In addition, the study will collect data to understand patient characteristics receiving this type of pacemaker.
Eligibility 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
Contact & Investigator
Tom Wong, MD
PRINCIPAL INVESTIGATOR
Royal Brompton and Harefield Hospital
Frequently Asked Questions
Who can join the NCT06854484 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Bradycardia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06854484 currently recruiting?
Yes, NCT06854484 is actively recruiting participants. Contact the research team at i.kralj-hans@rbht.nhs.uk for enrollment information.
Where is the NCT06854484 trial being conducted?
This trial is being conducted at London, United Kingdom, London, United Kingdom.
Who is sponsoring the NCT06854484 clinical trial?
NCT06854484 is sponsored by Royal Brompton & Harefield NHS Foundation Trust. The principal investigator is Tom Wong, MD at Royal Brompton and Harefield Hospital. The trial plans to enroll 300 participants.