Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Condition(s) studied
Investigational drug(s) / intervention(s)
Pacemaker implantation: De novo implantation, device upgrade to dual chamber or device replacement
Study summary
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.
Eligibility
Primary outcome measure(s)
- Right Atrial Autothreshold values at the inclusion and the M1-M3 visits — 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 — 1 to 3 months post-inclusion visit (M1-M3)
- Technical remote alerts documented at the M1-M3 visit — 1 to 3 months post-inclusion visit (M1-M3)
Trial sites (19)
| Facility | City | Region | Status |
|---|---|---|---|
| Universitätsklinikum Krems | Krems | Austria | Recruiting |
| Allgemeines Krankenhaus Wien | Vienna | Austria | Recruiting |
| Clinique Saint Joseph | Arlon | Belgium | Recruiting |
| CHU Bordeaux | Bordeaux | France | Recruiting |
| CH Chartres | Le Coudray | France | Recruiting |
| CHU Hôpital de la Timone | Marseille | France | Recruiting |
| CHU Nantes | Nantes | France | Recruiting |
| Clinique Pasteur Toulouse | Toulouse | France | Recruiting |
| CH Valence | Valence | France | Recruiting |
| Cardiologicum Hamburg | Hamburg | Germany | Recruiting |
| Cardiologicum Pirna | Pirna | Germany | Recruiting |
| Kardiologische Praxis Dr. Trautwein & Dr. Placke | Rostock | Germany | Recruiting |
| Ziekenhuis VieCuri Venlo | Venlo | Netherlands | Recruiting |
| Hospital Professor Doutor Fernando Fonseca | Amadora | Portugal | Recruiting |
| Hospital Arquitecto Marcide | Ferrol | Spain | Recruiting |
| Hospital Universitario Puerta de Hierro | Majadahonda | Spain | Recruiting |
| Basildon University Hospital | Basildon | United Kingdom | Not Yet Recruiting |
| Kingston Hospital | London | United Kingdom | Recruiting |
| Southend University Hospital | Westcliff-on-Sea | United Kingdom | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05165095 on ClinicalTrials.gov ↗ ← All trials in the UK