AVEIR™ Leadless Pacemaker (LP) United Kingdom (UK) Registry
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorRoyal Brompton & Harefield NHS Foundation Trust
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
AVEIR™leadless pacemaker
DeviceAVEIR™ leadless pacemaker implantation
Treatment groups
300 Participants
are divided into 1 treatment groupGroup A: Patients requiring leadless pacemaker insertion1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
5 years2
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.
Time frame
5 years3
Stimulation threshold (V) in the therapeutic zone
Minimum current needed to stimulate the paced chamber.
Time frame
5 years4
Percentage of stimulation in the therapeutic zone
Percentage of paced vs non paced heart beats.
Time frame
5 yearsSecondary outcomes
1
Age of patient (years) at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame
5 years2
Sex of patient at AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame
5 years3
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.
Time frame
5 years4
Indications for AVEIR ™ leadless pacemaker implantation
Collected as part of the demographics data for the patient group under investigation.
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov