Not yet recruiting NCT06782152

AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region (PREMIER LEADLESS)

— Observational Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines

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: This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to: Registry conditions: Cardiac Pacing in Adherence With ESC Cardiac Pacing Guidelines. 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: Center list to be confirmed — check the primary protocol.
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region

Overview

Detailed description

The AVEIR™ Leadless Pacemaker Registry (herein referred to as "PREMIER LEADLESS Registry") is a prospective, multicenter, International, open label observational study designed to evaluate safety and electrical performances of AVEIR™ leadless pacemakers used in real-world clinical practice and to evaluate clinical outcomes and characteristics of patients treated with these leadless devices. The study aims to evaluate safety profile, electrical performances and clinical outcomes in patients indicated for cardiac pacing after they receive Aveir LP systems. The Aveir VR LP system, for ventricular pacing, and the Aveir AR LP system for atrial pacing, and their concomitant use in the dual chamber configuration (Aveir DR LP system), have received the CE mark. The study also aims to understand clinical characteristics of patients receiving AVEIR™ leadless pacemaker devices in real-world clinical practice. The study Investigators will gather data from routine hospital practices and standard-of-care (SOC) procedures administered to patients. All devices used in these procedures are commercially available and already in use in the participating sites. The structure of this document provides a general overview and methodology of the study and a few specific details such as sample size, follow-up procedures, reporting requirements, and definitions.

Primary outcome measures

The primary safety endpoint is 1 year incidence rate of leadless device-related or procedure-related major complications. AveirTM LP systems [Time frame: 12 momths]
Acceptable ventricular pacing thresholds and R-wave amplitudes measured at 12 months. [Time frame: 12 months]
Acceptable atrial pacing thresholds and P-wave amplitudes as measured at 12 months. [Time frame: 12 months]

Secondary outcome measures (12)

Freedom from device- or procedure-related major complications at 24 months [Time frame: 24 months]
All adverse events, regardless device- or procedure-relatedness. [Time frame: 48 months]
Implant success rate and reasons for unsuccessful implant. [Time frame: 24 months]
Number of device repositioning at time of implantation. [Time frame: 24 months]
Implant duration, fluoroscopy duration, and time from implant to hospital discharge. [Time frame: 24 months]
Final LP placement site. [Time frame: 24 months]
Demographics and medical history, with specific focus on indication for pacemaker implant and reasons for the choice of leadless pacemakers. [Time frame: 24 months]
Device longevity, as displayed by the programmer at each visit. [Time frame: 48 months]
Device programming and pacing and sensing conditions which may impact longevity. [Time frame: 48 months]
Need for and success of device retrieval. [Time frame: 48 months]
Number of hospitalizations and mortality. [Time frame: 48 months]
Upgrade from Aveir VR to Aveir DR and from Aveir AR to Aveir DR.and Communication i2i success rate. [Time frame: 48 months]

Eligibility criteria

Inclusion criteria

Subject has clinical indication to cardiac pacing in adherence with ESC cardiac pacing guidelines.
Subject is ≥ 18 years of age or age of legal consent, whichever age is greater.
Subject agrees to return to clinic for the study follow-up visits.
Subject has been informed of the nature of the study, agrees to its provisions and has provided a signed written informed consent, approved by IRB/EC.

Exclusion criteria

Subject is currently participating in another study that may confound the results of this research.
Subject has a life expectancy less than 12 months.
Subject is pregnant or nursing or planning pregnancy during the study.
Subject has anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the study or to comply with the site standard follow-up visits, for example a mechanical tricuspid

\- Page 3 of 4 \[DRAFT\] - valve prosthesis or vein thrombosis, which could impede the delivery of implantable devices as planned by the implanters.

Subject is allergic/hypersensitive to <1 mg dexamethasone sodium phosphate.
Subject is implanted with an electrically active implantable medical device with stimulation capabilities at risk to be impacted by the Aveir Link Module telemetry.
Subject has known pacemaker syndrome, if that condition, in the investigator's opinion, represents a contraindication to the implant of the planned pacemaker.
Subject has pacing induced cardiomyopathy.

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

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06782152 · Version A

Primary sources (government registries)

ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗