AVEIR LP UK Registry
Research type
Research Study
Full title
AVEIR Leadless Pacemaker (LP) UK Registry
IRAS ID
340241
Contact name
Tom Wong
Contact email
Sponsor organisation
The Royal Brompton and Harefield Hospitals, Guy's and St Thomas' NHS Trust
Duration of Study in the UK
6 years, 11 months, 30 days
Research summary
AVEIR LP UK Registry is a study collecting data from patients who need to have a leadless pacemaker inserted due to underlying heart diseases. Leadless pacemaker technology promises to revolutionise care of the patients that require pacing. The AVEIR pacemaker is the newest of approved leadless pacemakers. Vigilant surveillance of its use in real clinical practice with respect to the effectiveness and safety of the device, at the time of the procedure as well as in the long-term, is essential to ensure that patients receive the best care. The focus is on the data related to the characteristics of the patients that need this type of pacemaker, the reasons why the pacemaker was chosen by their clinical care teams, the safety and efficacy of the device. We plan to recruit and consent 300 patients from up to 15 hospitals over 24 months and follow them up for 5 years.
The study is funded by Abbott Ltd and is Sponsored by the Royal Brompton and Harefield Hospitals, part of the Guy’s and St Thomas’ NHS Foundation Trust.
REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
24/EM/0235
Date of REC Opinion
7 Nov 2024
REC opinion
Further Information Favourable Opinion