BradycardiaCALLIOPENCT05165095
Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
An observational study of Bradycardia and Remote Monitoring, run by MicroPort CRM at 19 sites in 8 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Remote Monitoring
- What is being tested?
- Pacemaker implantation
- Type of treatment
- Medical device
- How many people
- 206 participants
- Where
- 19 sitesin 8 countries
- Study dates
- 25 Mar 2022to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
19 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
19 sites in 8 countries
France6 sites, 6 recruiting
- Recruiting
CHU Bordeaux
Bordeaux
Marc Strik
- Recruiting
CH Chartres
Le Coudray
Hervé Gorka
- Recruiting
CHU Hôpital de la Timone
Marseille
Jean-Claude Deharo
- Recruiting
CHU Nantes
Nantes
Vincent Probst
- Recruiting
Clinique Pasteur Toulouse
Toulouse
Romain Cassagneau
- Recruiting
CH Valence
Valence
Alexandre Guignier
Germany3 sites, 3 recruiting
- Recruiting
Cardiologicum Hamburg
Hamburg
Martin Bergmann
- Recruiting
Cardiologicum Pirna
Pirna
Christoph Axthelm
- Recruiting
Kardiologische Praxis Dr. Trautwein & Dr. Placke
Rostock
Jens Placke
United Kingdom3 sites, 3 recruiting
- Not yet recruiting
Basildon University Hospital
Basildon
Neil Srinivasan
- Recruiting
Kingston Hospital
London
Simon Pearse
- Recruiting
Southend University Hospital
Westcliff-on-Sea
Neil Srinivasan
Austria2 sites, 2 recruiting
- Recruiting
Universitätsklinikum Krems
Krems
Daniel Gerger
- Recruiting
Allgemeines Krankenhaus Wien
Vienna
Marianne Gwechenberger
Spain2 sites, 2 recruiting
- Recruiting
Hospital Arquitecto Marcide
Ferrol
Fernando Garcia López
- Recruiting
Hospital Universitario Puerta de Hierro
Majadahonda
Ignacio Fernandez-Lozano
Belgium1 site, 1 recruiting
- Recruiting
Clinique Saint Joseph
Arlon
Georges Mairesse
Netherlands1 site, 1 recruiting
- Recruiting
Ziekenhuis VieCuri Venlo
Venlo
Ronald Hazeleger
Portugal1 site, 1 recruiting
- Recruiting
Hospital Professor Doutor Fernando Fonseca
Amadora
Francisco Madeira
About this study
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.
Read the 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.
- Conditions
- Bradycardia, Remote Monitoring
- Being tested
- Pacemaker implantation
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker implantationDevice
De novo implantation, device upgrade to dual chamber or device replacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
Measured: 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
Measured: 1 to 3 months post-inclusion visit (M1-M3)
Technical remote alerts documented at the M1-M3 visit
Measured: 1 to 3 months post-inclusion visit (M1-M3)
Secondary outcomes (7)
Right Atrial Autothreshold values up to the M48 visit
Measured: 48 months post-inclusion visit (M48)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit
Measured: 48 months post-inclusion visit (M48)
Technical remote alerts documented up to the M48 visit
Measured: 48 months post-inclusion visit (M48)
Right Ventricular Autothreshold values up to the M48 visit
Measured: 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
Measured: 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
Measured: 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
Measured: 48 months post-inclusion visit (M48)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2021
- Study start25 Mar 2022
- Primary completion5 Sep 2023
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 206 participants (estimated)
Sponsor and investigators
- Lead sponsor
- MicroPort CRM
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05165095
- Sponsor's protocol ID
- IPBI01 - CALLIOPE
- Acronym
- CALLIOPE
- Status last verified
- May 2024
- First submitted
- 23 Nov 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Assessment of Essential Remote Monitoring Functions in Pacemakers
- ClinicalTrials.gov ID
- NCT05165095
- Acronym / sponsor ID
- CALLIOPE / IPBI01 - CALLIOPE
- Conditions
- Bradycardia, Remote Monitoring
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 206 participants (estimated)
- Lead sponsor
- MicroPort CRMIndustry (pharma, biotech, devices)
- Study start
- 25 Mar 2022 (actual)
- Primary completion
- 5 Sep 2023 (actual)
- Study completion
- Jul 2027 (estimated)
- First posted
- 21 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pacemaker implantationDe novo implantation, device upgrade to dual chamber or device replacement | Device | – |
Primary outcome
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
Time frame: 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
Time frame: 1 to 3 months post-inclusion visit (M1-M3)
Technical remote alerts documented at the M1-M3 visit
Time frame: 1 to 3 months post-inclusion visit (M1-M3)
7 secondary outcomes
Right Atrial Autothreshold values up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
In-clinic Right Ventricular pacing threshold values from Right Ventricular Autothreshold function up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Technical remote alerts documented up to the M48 visit
Time frame: 48 months post-inclusion visit (M48)
Right Ventricular Autothreshold values up to the M48 visit
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 48 months post-inclusion visit (M48)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Individual participant dataSharing planned: No
Related trials for Bradycardia
Not yet recruiting
nCPAP-NAVA-Backup Versus Standard nCPAP for Severe Apnea in Preterm Infants ≤28 Weeks
Apnea of Prematurity
RecruitingObservational study
Leadless Pacemaker Registry: Outcomes and Follow-up From the University Hospital of St. Pölten
Pacemaker, Leadless Pacemaker
RecruitingObservational study
Product Performance Report: Evaluate Long-term Reliability & Performance of Medtronic Marketed Cardiac Therapy Products
Arrhythmia, Bradycardia
Active, not recruitingObservational study
Safety, Performance, and Clinical Benefit of Pacing the Left Bundle Branch Area - Post-Market Clinical Follow-up
Bradycardia, Atrioventricular Block
RecruitingObservational study
BIO|STREAM.CSP Study
Cardiac Pacing, Cardiac Pacemaker
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
19 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bradycardia and Remote Monitoring, run by MicroPort CRM at 19 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France, Germany, United Kingdom, Austria, Spain and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Antoine Guihard (+33 1 46 01 33 20, antoine.guihard@crm.microport.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits (time frame: 1 to 3 months post-inclusion visit (M1-M3)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.