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

AVEIR™ Leadless Pacemaker United Kingdom 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.

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Syncope; Atrio-Ventricular Block
• Intervention / Treatment: Device: AVEIR™leadless pacemaker

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

• Study Contact: Name: Ines Kralj-Hans, PhD; Phone Number: 0330128 8854; Email: i.kralj-hans@rbht.nhs.uk
• Study Contact Backup: Name: Veronica Tudor; Phone Number: 0330128 8854; Email: v.tudor@rbht.nhs.uk

Study Locations

• United Kingdom
  • London, United Kingdom
    • Not yet recruiting
    • The Royal Brompton Hospital
    • Contact: Ines Kralj-Hans, PhD; Email: i.kralj-hans@rbht.nhs.uk
  • UK
    • London, UK, United Kingdom, SW3 6NP
      • Recruiting
      • Royal Brompton Hospital
      • Principal Investigator: Tom Wong, MD
      • Contact: Ines Kralj-Hans, PhD; Phone Number: 020 7352 8121; Email: i.kralj-hans@nhs.net
      • Contact: Veronica Tudor, PhD; Email: veronicaalina.tudor@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients requiring leadless pacemaker insertion; Patients who require leadless pacemaker to manage their heart condition	Device: AVEIR™leadless pacemaker; AVEIR™ leadless pacemaker implantation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	5 years
Stimulation threshold (V) in the therapeutic zone	Minimum current needed to stimulate the paced chamber.	5 years
Percentage of stimulation in the therapeutic zone	Percentage of paced vs non paced heart beats.	5 years
Impedance (Ohm) of R waves in the therapeutic zone	Physiological measure recorded by the device.	5 years
Amplitudes of R waves (mV) in the therapeutic zone	Physiological measure recorded by the device.	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Age of patient (years) at AVEIR ™ leadless pacemaker implantation	Collected as part of the demographics data for the patient group under investigation.	5 years
Sex of patient at AVEIR ™ leadless pacemaker implantation	Collected as part of the demographics data for the patient group under investigation.	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.	5 years
Indications for AVEIR ™ leadless pacemaker implantation	Collected as part of the demographics data for the patient group under investigation.	5 years

Collaborators and Investigators

• Sponsor: Royal Brompton & Harefield NHS Foundation Trust
• Investigators: Principal Investigator: Tom Wong, MD, Royal Brompton and Harefield Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2025
• Primary Completion (Estimated): March 1, 2032
• Study Completion (Estimated): September 1, 2032

Study Registration Dates

• First Submitted: January 28, 2025
• First Submitted That Met QC Criteria: February 26, 2025
• First Posted (Actual): March 3, 2025

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 24, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: AVEIR leadless pacemaker
• Additional Relevant MeSH Terms: Cardiac Conduction System Disease; Neurologic Manifestations; Nervous System Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Arrhythmias, Cardiac; Neurobehavioral Manifestations; Heart Block; Consciousness Disorders; Unconsciousness; Atrioventricular Block; Bradycardia; Syncope
• Other Study ID Numbers: AVEIR™ Registry; Medical Affairs CR24562 (Other Grant/Funding Number: Abbott Medical UK Ltd.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No