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NCT Number: NCT06854484

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

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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Key information

Conditions

Bradycardia Arrhythmias, Cardiac Atrio-Ventricular Block Cardiovascular Diseases Consciousness Disorders Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms Syncope Unconsciousness

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brompton Hospital, London, UK, United Kingdom

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

AVEIR™leadless pacemaker

Device

AVEIR™ leadless pacemaker implantation

Primary outcomes

  1. Percentage of patients without complications related to the device or implantation procedure.

    Time frame: 5 years

    Complications arising from the procedure or the device will be recorded to evaluate the success rate of the implantation.

  2. Percentage of patients requiring re-intervention.

    Time frame: 5 years

    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.

  3. Stimulation threshold (V) in the therapeutic zone

    Time frame: 5 years

    Minimum current needed to stimulate the paced chamber.

  4. Percentage of stimulation in the therapeutic zone

    Time frame: 5 years

    Percentage of paced vs non paced heart beats.

  5. Impedance (Ohm) of R waves in the therapeutic zone

    Time frame: 5 years

    Physiological measure recorded by the device.

  6. Amplitudes of R waves (mV) in the therapeutic zone

    Time frame: 5 years

    Physiological measure recorded by the device.

Secondary outcomes

  1. Age of patient (years) at AVEIR ™ leadless pacemaker implantation

    Time frame: 5 years

    Collected as part of the demographics data for the patient group under investigation.

  2. Sex of patient at AVEIR ™ leadless pacemaker implantation

    Time frame: 5 years

    Collected as part of the demographics data for the patient group under investigation.

  3. Medical history at AVEIR ™ leadless pacemaker implantation

    Time frame: 5 years

    List of significant cardiac or other comorbidities at the time of pacemaker implantation to describe patient population receiving AVEIR ™ leadless pacemaker.

  4. Indications for AVEIR ™ leadless pacemaker implantation

    Time frame: 5 years

    Collected as part of the demographics data for the patient group under investigation.

Study contacts

Contact information is provided by the study sponsor or research team.

Ines Kralj-Hans, PhD

CONTACT

[email protected]

0330128 8854

Veronica Tudor

CONTACT

[email protected]

0330128 8854

Sponsors and collaborators

Lead sponsor

Royal Brompton & Harefield NHS Foundation Trust

Other

Registry information

Official study title

AVEIR™ Leadless Pacemaker United Kingdom Registry

Important dates

Study start
2025
Primary completion
2032
Study completion
2032
First posted
Mar 3, 2025
Registry last updated
Jul 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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