Actively Recruiting

Age: 18Years +
All Genders
NCT06854484

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

Led by Royal Brompton & Harefield NHS Foundation Trust · Updated on 2025-07-29

300

Participants Needed

2

Research Sites

385 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patient is intended to receive or was treated with an AVEIR174 Leadless Transcatheter Pacing device
  • Subject is willing to comply with clinical investigation procedures and agrees to return for all required follow-up visits, tests, and exams
  • 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
Not Eligible

You will not qualify if you...

  • 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 Regional Ethics Committee

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Royal Brompton Hospital

London, UK, United Kingdom, SW3 6NP

Actively Recruiting

2

The Royal Brompton Hospital

London, United Kingdom

Not Yet Recruiting

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Research Team

I

Ines Kralj-Hans, PhD

CONTACT

V

Veronica Tudor

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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