NCT06854484

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
77mo left

Started Apr 2025

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Apr 2025Sep 2032

First Submitted

Initial submission to the registry

January 28, 2025

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2025

Completed
6.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2032

Expected
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2032

Last Updated

July 29, 2025

Status Verified

July 1, 2025

Enrollment Period

6.9 years

First QC Date

January 28, 2025

Last Update Submit

July 24, 2025

Conditions

BradycardiaAtrio-Ventricular BlockSyncope

Keywords

AVEIR leadless pacemaker

Outcome Measures

Primary Outcomes (6)

  • 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 Outcomes (4)

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

    5 years

  • Sex of patient at AVEIR ™ leadless pacemaker implantation

    5 years

  • Medical history at AVEIR ™ leadless pacemaker implantation

    5 years

  • Indications for AVEIR ™ leadless pacemaker implantation

    5 years

Study Arms (1)

Patients requiring leadless pacemaker insertion

Patients who require leadless pacemaker to manage their heart condition

Device: AVEIR™leadless pacemaker

Interventions

AVEIR™leadless pacemakerDEVICE

AVEIR™ leadless pacemaker implantation

Patients requiring leadless pacemaker insertion

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Royal Brompton Hospital

London, UK, SW3 6NP, United Kingdom

RECRUITING

The Royal Brompton Hospital

London, United Kingdom

NOT YET RECRUITING

MeSH Terms

Conditions

BradycardiaSyncope

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUnconsciousnessConsciousness DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and Symptoms

Study Officials

  • Tom Wong, MD

    Royal Brompton and Harefield Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ines Kralj-Hans, PhD

CONTACT

0330128 8854i.kralj-hans@rbht.nhs.uk

Veronica Tudor

CONTACT

0330128 8854v.tudor@rbht.nhs.uk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Target Duration
5 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 28, 2025

First Posted

March 3, 2025

Study Start

April 15, 2025

Primary Completion (Estimated)

March 1, 2032

Study Completion (Estimated)

September 1, 2032

Last Updated

July 29, 2025

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will not share

Locations

GB(2)