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Clinical Trial Details — Status: Recruiting

Administrative data

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

Study information

Verified date May 2024
Source MicroPort CRM
Contact Antoine Guihard
Phone +33 1 46 01 33 20
Email antoine.guihard@crm.microport.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Pacemaker implantation
De novo implantation, device upgrade to dual chamber or device replacement

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
MicroPort CRM

Countries where clinical trial is conducted

Austria,  Belgium,  France,  Germany,  Netherlands,  Portugal,  Spain,  United Kingdom, 

Outcome

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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