Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
CALLIOPE
1 other identifier
observational
206
8 countries
19
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2022
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 23, 2021
CompletedFirst Posted
Study publicly available on registry
December 21, 2021
CompletedStudy Start
First participant enrolled
March 25, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2027
ExpectedMay 31, 2024
May 1, 2024
1.4 years
November 23, 2021
May 30, 2024
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (7)
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)
- +2 more secondary outcomes
Interventions
De novo implantation, device upgrade to dual chamber or device replacement
Eligibility Criteria
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.
You may qualify if:
- 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)
- Patient implanted with an ALIZEA, BOREA or CELEA dual chamber pacemaker from MicroPort CRM
- Patient implanted with any active or passive CE marked bipolar RA lead, and any active or passive CE marked bipolar RV lead
- 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
- Patient reviewed, signed and dated the ICF
You may not qualify if:
- Patient with an elevated RV pacing threshold (strictly above 2.0 V for a pulse width of 0.5 ms or below)
- Patient with permanent AF
- Patient already enrolled in another clinical investigation that could confound the results of this clinical investigation (e.g., clinical investigations involving intra-cardiac device)
- 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)
- Minor age patient (i.e. under 18 years of age)
- Incapacitated patient, under guardianship, kept in detention, refusing to cooperate or not able to understand the purpose of this clinical investigation
- Patient unavailable for the follow-up visits scheduled
- Non-menopausal women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MicroPort CRMlead
Study Sites (19)
Universitätsklinikum Krems
Krems, Austria
Allgemeines Krankenhaus Wien
Vienna, 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
Cardiologicum Pirna
Pirna, Germany
Kardiologische Praxis Dr. Trautwein & Dr. Placke
Rostock, Germany
Ziekenhuis VieCuri Venlo
Venlo, Netherlands
Hospital Professor Doutor Fernando Fonseca
Amadora, Portugal
Hospital Arquitecto Marcide
Ferrol, Spain
Hospital Universitario Puerta de Hierro
Majadahonda, Spain
Basildon University Hospital
Basildon, United Kingdom
Kingston Hospital
London, United Kingdom
Southend University Hospital
Westcliff-on-Sea, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 23, 2021
First Posted
December 21, 2021
Study Start
March 25, 2022
Primary Completion
September 5, 2023
Study Completion (Estimated)
July 1, 2027
Last Updated
May 31, 2024
Record last verified: 2024-05
Data Sharing
- IPD Sharing
- Will not share