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

Recruitingn/aAges 18 Years - anyAllRoyal Brompton & Harefield NHS Foundation Trust
NCT06854484 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • AVEIR™leadless pacemaker
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Where

2 sites
Royal Brompton Hospital
London, United Kingdom
The Royal Brompton Hospital
London, United Kingdom
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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