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

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

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

Conditions4

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