An observational study in Bradycardia, Atrio-Ventricular Block and Syncope, sponsored by Royal Brompton & Harefield NHS Foundation Trust. Recruiting at 2 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-07-29.
Sponsored by Royal Brompton & Harefield NHS Foundation Trust · Observational
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.
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.
317 studies on the registry are indexed under Bradycardia; 71 are open to participants now.
This study's planned enrollment of 300 is above the median of 257 across 127 observational studies indexed under Bradycardia.
Browse Bradycardia studies →Royal Brompton & Harefield NHS Foundation Trust is the lead sponsor of 141 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Consecutive cardiology patients listed for leadless pacemaker implantation and fitted with AVEIR™ LP device in the usual clinical practice in the UK National Health Service centres.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients who require leadless pacemaker to manage their heart condition
Device: AVEIR™leadless pacemaker
AVEIR™ leadless pacemaker implantation
Percentage of patients without complications related to the device or implantation procedure.
Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation.
Time frame: 5 years
Percentage of patients requiring re-intervention.
Replacement, explant, upgrade, or modification of the position of the device are considered re-interventions which will be used to evaluate safety of the device.
Time frame: 5 years
Stimulation threshold (V) in the therapeutic zone
Minimum current needed to stimulate the paced chamber.
Time frame: 5 years
Percentage of stimulation in the therapeutic zone
Percentage of paced vs non paced heart beats.
Time frame: 5 years
Impedance (Ohm) of R waves in the therapeutic zone
Physiological measure recorded by the device.
Time frame: 5 years
Amplitudes of R waves (mV) in the therapeutic zone
Physiological measure recorded by the device.
Time frame: 5 years
Age of patient (years) at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame: 5 years
Sex of patient at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame: 5 years
Medical history at AVEIR ™ leadless pacemaker implantation
List of significant cardiac or other comorbidities at the time of pacemaker implantation to describe patient population receiving AVEIR ™ leadless pacemaker.
Time frame: 5 years
Indications for AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Royal Brompton & Harefield NHS Foundation Trust →