AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust
About this trial
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 criteria
Qualifiers
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; and
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).
Disqualifiers
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
Trial design
Treatments tested in this trial
- AVEIR™leadless pacemaker
Treatment groups
300 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov