Recruiting NCT05165095
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
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
- The protocol lists: Pacemaker implantation.
- Who it may be relevant to
- Registry conditions: Bradycardia, Remote Monitoring. 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
- Austria, Belgium, France, Germany, Netherlands +3
- 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 →
Overview
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.
Detailed description
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.
Interventions
- Device Pacemaker implantation
De novo implantation, device upgrade to dual chamber or device replacement
Primary outcome measures
- Right Atrial Autothreshold values at the inclusion and the M1-M3 visits [Time frame: 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 [Time frame: 1 to 3 months post-inclusion visit (M1-M3)]
- Technical remote alerts documented at the M1-M3 visit [Time frame: 1 to 3 months post-inclusion visit (M1-M3)]
Secondary outcome measures (7)
- Right Atrial Autothreshold values up to the M48 visit [Time frame: 48 months post-inclusion visit (M48)]
- In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit [Time frame: 48 months post-inclusion visit (M48)]
- Technical remote alerts documented up to the M48 visit [Time frame: 48 months post-inclusion visit (M48)]
- Right Ventricular Autothreshold values up to the M48 visit [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: 48 months post-inclusion visit (M48)]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
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
France · 6 centers
- CHU Bordeaux — Bordeaux
- CH Chartres — Le Coudray
- CHU Hôpital de la Timone — Marseille
- CHU Nantes — Nantes
- Clinique Pasteur Toulouse — Toulouse
- CH Valence — Valence
Germany · 3 centers
- Cardiologicum Hamburg — Hamburg
- Cardiologicum Pirna — Pirna
- Kardiologische Praxis Dr. Trautwein & Dr. Placke — Rostock
United Kingdom · 3 centers
- Basildon University Hospital — Basildon
- Kingston Hospital — London
- Southend University Hospital — Westcliff-on-Sea
Austria · 2 centers
- Universitätsklinikum Krems — Krems
- Allgemeines Krankenhaus Wien — Vienna
Spain · 2 centers
- Hospital Arquitecto Marcide — Ferrol
- Hospital Universitario Puerta de Hierro — Majadahonda
Belgium · 1 center
- Clinique Saint Joseph — Arlon
Netherlands · 1 center
- Ziekenhuis VieCuri Venlo — Venlo
Portugal · 1 center
- Hospital Professor Doutor Fernando Fonseca — Amadora
Identifiers
NCT: NCT05165095 · IPBI01 - CALLIOPE