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

Launched by ROYAL BROMPTON & HAREFIELD NHS FOUNDATION TRUST · Feb 26, 2025

Keywords

ClinConnect Summary

The AVEIR™ Leadless Pacemaker UK Registry is a study designed to follow patients who need a leadless pacemaker for their heart conditions, such as bradycardia (a slow heart rate), atrio-ventricular block (a delay in the heart's electrical signals), or syncope (fainting). Over five years, researchers will look at how safe and effective the AVEIR™ leadless pacemaker is when used in regular healthcare settings across the UK. They will also gather information about the patients who receive this type of pacemaker to better understand their needs.

To be eligible for the study, patients should be planning to receive the AVEIR™ leadless pacemaker and must be willing to attend follow-up visits and tests. It's important that they understand the study and agree to participate by signing a consent form. However, if a cardiologist decides that a patient is not suitable for the device or if the patient does not want to comply with the study procedures, they won't be able to join. Those who do participate can expect regular check-ins over the years to monitor their progress and health outcomes with the pacemaker.

Gender

ALL

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