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Recruiting NCT06854484

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

— Observational Bradycardia Atrio-Ventricular Block Syncope

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: AVEIR™leadless pacemaker.
Who it may be relevant to
Registry conditions: Bradycardia, Atrio-Ventricular Block, Syncope. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

AVEIR™ Leadless Pacemaker United Kingdom Registry

Overview

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.

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.

Interventions

  • Device AVEIR™leadless pacemaker
    AVEIR™ leadless pacemaker implantation

Primary outcome measures

  • Percentage of patients without complications related to the device or implantation procedure. [Time frame: 5 years]
  • Percentage of patients requiring re-intervention. [Time frame: 5 years]
  • Stimulation threshold (V) in the therapeutic zone [Time frame: 5 years]
  • Percentage of stimulation in the therapeutic zone [Time frame: 5 years]
  • Impedance (Ohm) of R waves in the therapeutic zone [Time frame: 5 years]
  • Amplitudes of R waves (mV) in the therapeutic zone [Time frame: 5 years]
Secondary outcome measures (4)
  • Age of patient (years) at AVEIR ™ leadless pacemaker implantation [Time frame: 5 years]
  • Sex of patient at AVEIR ™ leadless pacemaker implantation [Time frame: 5 years]
  • Medical history at AVEIR ™ leadless pacemaker implantation [Time frame: 5 years]
  • Indications for AVEIR ™ leadless pacemaker implantation [Time frame: 5 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 2 centers
  • Royal Brompton Hospital — London
  • The Royal Brompton Hospital — London

Identifiers

NCT: NCT06854484 · AVEIR™ Registry · Medical Affairs CR24562

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗