Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Last updated: May 30, 2024
Sponsor: MicroPort CRM
Overall Status: Active - Recruiting

Phase

N/A

Condition

Arrhythmia

Heart Defect

Heart Disease

Treatment

Pacemaker implantation

Clinical Study ID

NCT05165095
IPBI01 - CALLIOPE
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient implanted according to the most recent guidelines from the ESC, for 20 daysor less (de novo implantation, device upgrade to dual chamber or device replacement)

  2. Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker fromMicroPort CRM

  3. Patient implanted with any active or passive CE marked bipolar RA lead, and anyactive or passive CE marked bipolar RV lead

  4. Patient's pacemaker with the remote monitoring functions (i.e. the RAAT, the RVATand the remote alerts) accepted by the patient and planned to be activated

  5. Patient reviewed, signed and dated the ICF

Exclusion

Exclusion Criteria:

  1. Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse widthof 0.5 ms or below)

  2. Patient with permanent AF

  3. Patient already enrolled in another clinical investigation that could confound theresults of this clinical investigation (e.g., clinical investigations involvingintra-cardiac device)

  4. Patient implanted despite a contraindication for cardiac pacing system implantation (i.e. patient implanted with a defibrillator, patient contraindicated for a singledose of 310 μg of dexamethasone sodium phosphate, patient implanted with a tricuspidreplacement heart valve or with a significant tricuspid valve disease that may leadto 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 cooperateor 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

Total Participants: 206
Treatment Group(s): 1
Primary Treatment: Pacemaker implantation
Phase:
Study Start date:
March 25, 2022
Estimated Completion Date:
July 31, 2027

Study 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.

Connect with a study center

  • Universitätsklinikum Krems

    Krems,
    Austria

    Active - Recruiting

  • Allgemeines Krankenhaus Wien

    Wien,
    Austria

    Active - Recruiting

  • Clinique Saint Joseph

    Arlon,
    Belgium

    Active - Recruiting

  • CHU Bordeaux

    Bordeaux,
    France

    Active - Recruiting

  • CH Chartres

    Le Coudray,
    France

    Active - Recruiting

  • CHU Hôpital de la Timone

    Marseille,
    France

    Active - Recruiting

  • CHU Nantes

    Nantes,
    France

    Active - Recruiting

  • Clinique Pasteur Toulouse

    Toulouse,
    France

    Active - Recruiting

  • CH Valence

    Valence,
    France

    Active - Recruiting

  • Cardiologicum Hamburg

    Hamburg,
    Germany

    Active - Recruiting

  • Cardiologicum Pirna

    Pirna,
    Germany

    Active - Recruiting

  • Kardiologische Praxis Dr. Trautwein & Dr. Placke

    Rostock,
    Germany

    Active - Recruiting

  • Ziekenhuis VieCuri Venlo

    Venlo,
    Netherlands

    Active - Recruiting

  • Hospital Professor Doutor Fernando Fonseca

    Amadora,
    Portugal

    Active - Recruiting

  • Hospital Arquitecto Marcide

    Ferrol,
    Spain

    Active - Recruiting

  • Hospital Universitario Puerta de Hierro

    Majadahonda,
    Spain

    Active - Recruiting

  • Basildon University Hospital

    Basildon,
    United Kingdom

    Site Not Available

  • Kingston Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Southend University Hospital

    Westcliff-on-Sea,
    United Kingdom

    Active - Recruiting

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