At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- AVEIR™leadless pacemaker (device)
- How long the study runs
- Study runs about 89 months (dates as stated)
- About the drug or intervention
- AVEIR™leadless pacemaker — device: AVEIR™ leadless pacemaker implantation
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Observing health over time
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 300
- Started
- 2025-04-15
- Last checked
- 2025-07
Plain English Summary
What is this study?
- • Testing a new treatment for bradycardia
- • Clinical study - 300 participants
- • This observational study will follow patients requiring implantation of leadless pacemaker for 5 years after implantation
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with bradycardia
Where?
- • London - Royal Brompton Hospital
- • London - The Royal Brompton Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
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.
More detail
AVEIR™ stimulator (Abbott) obtained the approvals in July 2023 and started to be implanted in patients in Europe. As a leadless pacemaker, the AVEIR™ Leadless Pacemaker (LP) does not need a connector, pacing lead, or pulse generator pocket. The LP is delivered percutaneously via the femoral vein through an AVEIR™ Introducer and Delivery Catheter. AVEIR™ LP is intended to provide bradycardia pacing as a pulse generator with built-in battery and electrodes for implantation. The LP is intended to provide sensing of intrinsic cardiac signals and delivery of cardiac pacing therapy to the target treatment group. The purpose of this study is to understand long term safety and performance characteristic of this device. In addition, the study will collect anonymous clinical data and characteristics of the patients chosen to be implanted with AVEIR™ leadless pacemaker in routine clinical practice in approved centres across the UK. Six hundred patients will be recruited in up to 15 centres during 2 years recruitment period. They will be followed up for 5 years after implantation of the leadless pacemaker. Investigators will record their age, sex, medical history, indications for receiving AVEIR™ and any complications related to the implantation procedure or the device itself. All the data will be collected in an anonymous format. Patients will be followed up according to the standard of care in the national health care system.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Treatment history
Treatments you must have had:
- ✓ follow-up visits, tests, and exams
What the study is looking for
- ✓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...
- ✓Subject has been informed of the nature of the study, agrees to its provisions, and has provided a signed written...
Who cannot take part
- ✗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...
- ✗Subject has been informed of the nature of the study, but does not agree to its provisions, and has not provided a...
See the full criteria
Where Is This Study? (2 UK sites)
Royal Brompton Hospital
London SW3 6NP, United Kingdom
The Royal Brompton Hospital
London, United Kingdom
How to Get in Touch
Ines Kralj-Hans, PhD
Sponsor contactCONTACT
Veronica Tudor
Sponsor contactCONTACT