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

Официальное название

AVEIR™ Leadless Pacemaker Registry in Europe and MIddle East Region

Обзор

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.

Подробное описание

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.

Первичные конечные точки

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

Вторичные конечные точки (12)

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

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06782152 · Version A

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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