Bradycardia Clinical Trial
— CALLIOPEOfficial title:
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
NCT number | NCT05165095 |
Other study ID # | IPBI01 - CALLIOPE |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | March 25, 2022 |
Est. completion date | July 2027 |
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.
Status | Recruiting |
Enrollment | 206 |
Est. completion date | July 2027 |
Est. primary completion date | September 5, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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) 2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM 3. Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead 4. 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 5. Patient reviewed, signed and dated the ICF Exclusion Criteria: 1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below) 2. Patient with permanent AF 3. Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device) 4. 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) 5. Minor age patient (i.e. under 18 years of age) 6. Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation 7. Patient unavailable for the follow-up visits scheduled 8. Non-menopausal women |
Country | Name | City | State |
---|---|---|---|
Austria | Universitätsklinikum Krems | Krems | |
Austria | Allgemeines Krankenhaus Wien | Wien | |
Belgium | Clinique Saint Joseph | Arlon | |
France | CHU Bordeaux | Bordeaux | |
France | CH Chartres | Le Coudray | |
France | CHU Hôpital de la Timone | Marseille | |
France | CHU Nantes | Nantes | |
France | Clinique Pasteur Toulouse | Toulouse | |
France | CH Valence | Valence | |
Germany | Cardiologicum Hamburg | Hamburg | |
Germany | Cardiologicum Pirna | Pirna | |
Germany | Kardiologische Praxis Dr. Trautwein & Dr. Placke | Rostock | |
Netherlands | Ziekenhuis VieCuri Venlo | Venlo | |
Portugal | Hospital Professor Doutor Fernando Fonseca | Amadora | |
Spain | Hospital Arquitecto Marcide | Ferrol | |
Spain | Hospital Universitario Puerta de Hierro | Majadahonda | |
United Kingdom | Basildon University Hospital | Basildon | |
United Kingdom | Kingston Hospital | London | |
United Kingdom | Southend University Hospital | Westcliff-on-Sea |
Lead Sponsor | Collaborator |
---|---|
MicroPort CRM |
Austria, Belgium, France, Germany, Netherlands, Portugal, Spain, United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Right Atrial Autothreshold values at the inclusion and the M1-M3 visits | 1 to 3 months post-inclusion visit (M1-M3) | ||
Primary | 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) | ||
Primary | Technical remote alerts documented at the M1-M3 visit | 1 to 3 months post-inclusion visit (M1-M3) | ||
Secondary | Right Atrial Autothreshold values up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | Technical remote alerts documented up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | Right Ventricular Autothreshold values up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | Safety of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | Electrical performances (pacing thresholds, impedance & minimum sensed amplitude) of ALIZEA, BOREA and CELEA pacemaker systems up to the M48 visit | 48 months post-inclusion visit (M48) | ||
Secondary | Usability of ALIZEA, BOREA and CELEA pacemaker and of SMARTVIEW CONNECT remote monitoring systems up to the M48 visit | 48 months post-inclusion visit (M48) |
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