Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Обзор

The purpose of the clinical investigation is to document the safety and the performances of the remote monitoring functions of the ALIZEA, BOREA and CELEA pacemakers, i.e. the RAAT, the RVAT and the remote alerts.

Подробное описание

All patients will be included just after implantation and will then be followed during 48 months after inclusion.

At each on-site or remote follow-up visit (1 to 3 months, 6, 12, 24 and 48 months), performances of the remote monitoring functions and the cardiac pacing system itself will be measured, and safety will be monitored during the whole clinical investigation duration.

Вмешательства

• Устройство Pacemaker implantation
  De novo implantation, device upgrade to dual chamber or device replacement

Первичные конечные точки

• Right Atrial Autothreshold values at the inclusion and the M1-M3 visits [Срок оценки: 1 to 3 months post-inclusion visit (M1-M3)]
• In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function at the inclusion and the M1-M3 visits [Срок оценки: 1 to 3 months post-inclusion visit (M1-M3)]
• Technical remote alerts documented at the M1-M3 visit [Срок оценки: 1 to 3 months post-inclusion visit (M1-M3)]

Вторичные конечные точки (7)

• Right Atrial Autothreshold values up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• Technical remote alerts documented up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• Right Ventricular Autothreshold values up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• Safety of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• Electrical performances (pacing thresholds, impedance & minimum sensed amplitude) of ALIZEA, BOREA and CELEA pacemaker systems up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]
• Usability of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit [Срок оценки: 48 months post-inclusion visit (M48)]

Критерии участия

Критерии включения

• Patient implanted according to the most recent guidelines from the ESC, for 20 days or less (de novo implantation, device upgrade to dual chamber or device replacement)
• Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
• Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
• Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVAT and the remote alerts) accepted by the patient and planned to be activated
• Patient reviewed, signed and dated the ICF

Критерии исключения

• Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
• Patient with permanent AF
• Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
• Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a single dose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspid replacement heart valve or with a significant tricuspid valve disease that may lead to future replacement heart valve surgery)
• Minor age patient (i.e. under 18 years of age)
• Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
• Patient unavailable for the follow-up visits scheduled
• Non-menopausal women

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Франция · 6 центров

• CHU Bordeaux — Bordeaux
• CH Chartres — Le Coudray
• CHU Hôpital de la Timone — Marseille
• CHU Nantes — Nantes
• Clinique Pasteur Toulouse — Toulouse
• CH Valence — Valence

Германия · 3 центра

• Cardiologicum Hamburg — Hamburg
• Cardiologicum Pirna — Pirna
• Kardiologische Praxis Dr. Trautwein & Dr. Placke — Rostock

Великобритания · 3 центра

• Basildon University Hospital — Basildon
• Kingston Hospital — London
• Southend University Hospital — Westcliff-on-Sea

Австрия · 2 центра

• Universitätsklinikum Krems — Krems
• Allgemeines Krankenhaus Wien — Vienna

Испания · 2 центра

• Hospital Arquitecto Marcide — Ferrol
• Hospital Universitario Puerta de Hierro — Majadahonda

Бельгия · 1 центр

• Clinique Saint Joseph — Arlon

Нидерланды · 1 центр

• Ziekenhuis VieCuri Venlo — Venlo

Португалия · 1 центр

• Hospital Professor Doutor Fernando Fonseca — Amadora

Идентификаторы

NCT: NCT05165095 · IPBI01 - CALLIOPE

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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