Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers (CALLIOPE)

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.

Study Overview

• Status: Recruiting
• Conditions: Bradycardia; Remote Monitoring
• Intervention / Treatment: Device: Pacemaker implantation

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 Type: Observational
• Enrollment (Estimated): 206

Contacts and Locations

• Study Contact: Name: Antoine Guihard; Phone Number: +33 1 46 01 33 20; Email: antoine.guihard@crm.microport.com

Study Locations

• Austria
  • Krems, Austria
    • Recruiting
    • Universitätsklinikum Krems
    • Contact: Daniel Gerger
  • Wien, Austria
    • Recruiting
    • Allgemeines Krankenhaus Wien
    • Contact: Marianne Gwechenberger
• Belgium
  • Arlon, Belgium
    • Recruiting
    • Clinique Saint Joseph
    • Contact: Georges Mairesse
• France
  • Bordeaux, France
    • Recruiting
    • CHU Bordeaux
    • Contact: Marc Strik
  • Le Coudray, France
    • Recruiting
    • CH Chartres
    • Contact: Hervé GORKA
  • Marseille, France
    • Recruiting
    • CHU Hôpital de la Timone
    • Contact: Jean-Claude DEHARO
  • Nantes, France
    • Recruiting
    • CHU Nantes
    • Contact: Vincent Probst
  • Toulouse, France
    • Recruiting
    • Clinique Pasteur Toulouse
    • Contact: Romain Cassagneau
  • Valence, France
    • Recruiting
    • Ch Valence
    • Contact: Alexandre GUIGNIER
• Germany
  • Hamburg, Germany
    • Recruiting
    • Cardiologicum Hamburg
    • Contact: Martin Bergmann
  • Pirna, Germany
    • Recruiting
    • Cardiologicum Pirna
    • Contact: Christoph Axthelm
  • Rostock, Germany
    • Recruiting
    • Kardiologische Praxis Dr. Trautwein & Dr. Placke
    • Contact: Jens Placke
• Netherlands
  • Venlo, Netherlands
    • Recruiting
    • Ziekenhuis VieCuri Venlo
    • Contact: Ronald Hazeleger
• Portugal
  • Amadora, Portugal
    • Recruiting
    • Hospital Professor Doutor Fernando Fonseca
    • Contact: Francisco Madeira
• Spain
  • Ferrol, Spain
    • Recruiting
    • Hospital Arquitecto Marcide
    • Contact: Fernando Garcia López
  • Majadahonda, Spain
    • Recruiting
    • Hospital Universitario Puerta De Hierro
    • Contact: Ignacio Fernandez-Lozano
• United Kingdom
  • Basildon, United Kingdom
    • Not yet recruiting
    • Basildon University Hospital
    • Contact: Neil Srinivasan
  • London, United Kingdom
    • Recruiting
    • Kingston Hospital
    • Contact: Simon Pearse
  • Westcliff-on-Sea, United Kingdom
    • Recruiting
    • Southend University Hospital
    • Contact: Neil Srinivasan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients indicated (class I or II) for a dual chamber pacemaker (de novo implantation, device upgrade to dual chamber or device replacement), according to the most recent guidelines from the ESC.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: MicroPort CRM

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2022
• Primary Completion (Estimated): July 1, 2023
• Study Completion (Estimated): July 1, 2027

Study Registration Dates

• First Submitted: November 23, 2021
• First Submitted That Met QC Criteria: December 6, 2021
• First Posted (Actual): December 21, 2021

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 2, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Bradycardia
• Other Study ID Numbers: IPBI01 - CALLIOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No