Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Recruiting

• Conditions: Bradycardia; Remote Monitoring

• Registration Number: NCT05165095
• Lead Sponsor: MicroPort CRM

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-11-23
• Study First Submitted QC: 2021-12-06
• Study First Posted: 2021-12-21
• Study Start: 2022-03-25
• Primary Completion: 2023-09-05
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31
• Study Completion: 2027-07

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 206

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Technical remote alerts documented at the M1-M3 visit	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)
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits	1 to 3 months post-inclusion visit (M1-M3)

Secondary Outcome Measures

Name	Time	Method
Right Ventricular Autothreshold values up to the M48 visit	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	48 months post-inclusion visit (M48)
Right Atrial Autothreshold values up to the M48 visit	48 months post-inclusion visit (M48)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit	48 months post-inclusion visit (M48)
Technical remote alerts documented up to the M48 visit	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	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	48 months post-inclusion visit (M48)

Trial Locations

Locations (19)

Universitätsklinikum Krems; 🇦🇹 Krems, Austria

Allgemeines Krankenhaus Wien; 🇦🇹 Wien, Austria

Clinique Saint Joseph; 🇧🇪 Arlon, Belgium

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, France

Cardiologicum Hamburg; 🇩🇪 Hamburg, Germany

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