Clinical trial NCT06854484: AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
Official title: AVEIR™ Leadless Pacemaker United Kingdom Registry
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Bradycardia
Atrio-Ventricular Block
Syncope
Keywords: AVEIR leadless pacemaker
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Percentage of patients without complications related to the device or implantation procedure.
timeFrame: 5 years
measure: Percentage of patients requiring re-intervention.
timeFrame: 5 years
measure: Stimulation threshold (V) in the therapeutic zone
timeFrame: 5 years
measure: Percentage of stimulation in the therapeutic zone
timeFrame: 5 years
measure: Impedance (Ohm) of R waves in the therapeutic zone
timeFrame: 5 years
measure: Amplitudes of R waves (mV) in the therapeutic zone
timeFrame: 5 years
Secondary outcomes:
measure: Age of patient (years) at AVEIR ™ leadless pacemaker implantation
timeFrame: 5 years
measure: Sex of patient at AVEIR ™ leadless pacemaker implantation
timeFrame: 5 years
measure: Medical history at AVEIR ™ leadless pacemaker implantation
timeFrame: 5 years
measure: Indications for AVEIR ™ leadless pacemaker implantation
timeFrame: 5 years
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: The Royal Brompton Hospital
Study officials:
affiliation: Royal Brompton and Harefield Hospital
name: Tom Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: