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CALLIOPE: Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers

Sponsor
MicroPort CRM (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05165095
Collaborator
(none)
206
Enrollment
4
Locations
56.2
Anticipated Duration (Months)
51.5
Patients Per Site
0.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
206 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
Actual Study Start Date :
Mar 25, 2022
Anticipated Primary Completion Date :
Jan 1, 2023
Anticipated Study Completion Date :
Dec 1, 2026

Outcome Measures

Primary Outcome Measures

  1. Right Atrial Autothreshold values at the inclusion and the M1-M3 visits [1 to 3 months post-inclusion visit (M1-M3)]

  2. 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)]

  3. Technical remote alerts documented at the M1-M3 visit [1 to 3 months post-inclusion visit (M1-M3)]

Secondary Outcome Measures

  1. Right Atrial Autothreshold values up to the M48 visit [48 months post-inclusion visit (M48)]

  2. In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit [48 months post-inclusion visit (M48)]

  3. Technical remote alerts documented up to the M48 visit [48 months post-inclusion visit (M48)]

  4. Right Ventricular Autothreshold values up to the M48 visit [48 months post-inclusion visit (M48)]

  5. 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)]

  6. 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)]

  7. 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)]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Clinique Saint Joseph Arlon Belgium
2 CHU Bordeaux Bordeaux France
3 Hôpital Louis Pasteur Le Coudray France
4 Hôpital de la Timone Marseille France

Sponsors and Collaborators

  • MicroPort CRM

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
MicroPort CRM
ClinicalTrials.gov Identifier:
NCT05165095
Other Study ID Numbers:
  • IPBI01 - CALLIOPE
First Posted:
Dec 21, 2021
Last Update Posted:
Apr 12, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Bradycardia

Study Results

No Results Posted as of Apr 12, 2022