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

May 30, 2024 updated by: MicroPort CRM
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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
206

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Austria
      • Krems, Austria
        • Recruiting
        • Universitatsklinikum 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 Hopital 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Right Atrial Autothreshold values at the inclusion and the M1-M3 visits
Time Frame: 1 to 3 months post-inclusion visit (M1-M3)
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)
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)
1 to 3 months post-inclusion visit (M1-M3)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Right Atrial Autothreshold values up to the M48 visit
Time Frame: 48 months post-inclusion visit (M48)
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)
48 months post-inclusion visit (M48)
Technical remote alerts documented up to the M48 visit
Time Frame: 48 months post-inclusion visit (M48)
48 months post-inclusion visit (M48)
Right Ventricular Autothreshold values up to the M48 visit
Time Frame: 48 months post-inclusion visit (M48)
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)
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)
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)
48 months post-inclusion visit (M48)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
MicroPort CRM

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 5, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 23, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 21, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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