Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Bradycardia Clinical Trial

— CALLIOPE  

Official title:

Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05165095
• Other study ID #: IPBI01 - CALLIOPE
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Bradycardia
• Remote Monitoring

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)