Long-Term Safety and Performance Study of AVEIR Leadless Pacemaker in UK Patients Observational Registry Following Patients With Bradycardia and Related Heart Conditions

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 devices long-term use in routine clinical settings.

AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry