Actively Recruiting
AVEIR™ Leadless Pacemaker United Kingdom Registry
Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2025-07-29
300
Participants Needed
2
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the long-term safety and performance of the AVEIR™ leadless pacemaker in patients who need this device to manage heart conditions such as bradycardia, atrio-ventricular block, and syncope. This observational study is conducted within the UK National Health Service and aims to collect clinical data on patient characteristics and device outcomes in real-world settings. The study plans to recruit 600 patients across up to 15 centers over a 2-year period. The AVEIR™ leadless pacemaker is a device implanted without traditional leads or a pulse generator pocket. It is inserted through the femoral vein using a delivery catheter and provides cardiac pacing and sensing for bradycardia treatment. Patients will receive the device as part of their usual care, and their progress will be observed for 5 years following implantation to evaluate device-related complications, need for re-intervention, and device performance measures such as stimulation threshold and signal amplitudes. Participants will be followed according to standard clinical practice with data collected anonymously, including age, sex, medical history, and indications for pacemaker implantation. The study will monitor safety and efficacy outcomes over 5 years, with assessments focusing on complications related to the device or implantation procedure, pacing thresholds, and cardiac signal measurements. This extended follow-up period aims to provide valuable insights into the device's long-term use in routine clinical settings.
CONDITIONS
Brief Title
AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
- 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)
You will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 2 years (recruitment period)
Participants undergo implantation of the AVEIR™ leadless pacemaker as part of routine clinical care.
1 implantation visit
Duration - 5 years
Participants are followed for up to 5 years after implantation to observe the safety and performance of the leadless pacemaker in routine clinical practice.
Follow-up visits according to standard of care in the national health care system
Trial Site Locations
Total: 2 locations
1
Royal Brompton Hospital
London, UK, United Kingdom, SW3 6NP
Actively Recruiting
2
The Royal Brompton Hospital
London, United Kingdom
Not Yet Recruiting
Research Team
I
Ines Kralj-Hans, PhD
V
Veronica Tudor
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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