PacemakerREACT 2NCT06272344
Remote Programming of Cardiac Implantable Electronic Devices 2
A study testing Teleconsultation in people with Pacemaker and Defibrillator, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pacemaker, Defibrillator, Telemedecine
- What is being tested?
- Teleconsultation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteFrance
- Study dates
- 24 Apr 2023to 2 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Patient of both sexes over the age of 18
- Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming)
- Patient followed at the Bordeaux University Hospital but living more than 90km away
- Person beneficiary of social security insurance
- Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research)
- Women of procreating age with effective contraception
Who cannot join
- Patients younger than 18 years old
- Patients who are incapable to understand the study design or to give informed consent.
- Pregnant or breastfeeding women
- Persons placed under legal protection
- Subject deprived of liberty on judicial or administrative decision
- Persons participating in another study who are still in their period of exclusion
Trial locations and contacts
1 site in 1 country.
About this study
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. The aim of this study is to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.
Read the detailed description
Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists and the possibility to offer expert support at remote locations or developing countries. Remote programming may be a way to mitigate disparities in health care access. The remote surveillance centre of CHU Bordeaux has previously developed and validated (REACT study, NCT05366660) a remote control system for CIED programmers that eliminates the physical presence of a cardiologist during the interrogation and programming process. The aim of this study is to evaluate this solution for the remote evaluation of CIEDs at the benefit of inhabitant of medically underserved population. Enrolled patients living >100km from the Bordeaux University Hospital will undergo there an in person evaluation of their CIED which will be compared six months later with a remote evaluation in a nurse office close to the patient's home.
- Conditions
- Pacemaker, Defibrillator, Telemedecine
- Being tested
- Teleconsultation
- Keywords
- Implantable cardioverter defibrillator, ICD, Telemedecine, Remote monitoring, Remote programming, Cardiac implantable electronical device, Medically underserved population, Medically underserved area, Health professional shortage area
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeleconsultationOther
Teleconsultation at 6 months
| Study group | Role | What they receive |
|---|---|---|
| Teleconsultation | Experimental | Teleconsultation at 6 months Receives: Other: Teleconsultation |
What is being measured
The primary outcome is the main question the study is designed to answer.
assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital
Patient satisfaction
Measured: 6 months
Secondary outcomes (4)
Time saving for patient
Time of consultation and teleconsultation
Measured: 6 months
Savings on medical transport
Cost of medical transports for consultation and teleconsultation
Measured: 6 months
Costs associated with teleconsultation
Global amount of costs for teleconsultation
Measured: 6 months
safety of teleconsultation
Number of Adverse Events and technical incidents
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start24 Apr 2023
- Primary completion2 Apr 2024
- Study completion2 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PacemakerStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective, single-center, single-arm, pairwise comparison trial
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sylvain MD PLOUX, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272344
- Sponsor's protocol ID
- CHUBX 2022/38
- Acronym
- REACT 2
- Status last verified
- Jun 2025
- First submitted
- 15 Feb 2024
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ploux S, Strik M, Varma N, Bouteiller XP, Carlier L, Lissandreau S, Ben Boujema T, Boursier D, Hugot E, Haissaguerre M, Benali K, Bordachar P. Bridging the Gap: Remote Evaluation and Programming of Cardiac Implantable Devices in Medically Underserved Areas. JACC Clin Electrophysiol. 2025 Jan;11(1):171-178. doi: 10.1016/j.jacep.2024.09.027. Epub 2024 Nov 27.
PubMed 39614866
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Programming of Cardiac Implantable Electronic Devices 2
- ClinicalTrials.gov ID
- NCT06272344
- Acronym / sponsor ID
- REACT 2 / CHUBX 2022/38
- Conditions
- Pacemaker, Defibrillator, Telemedecine
- Keywords
- Implantable cardioverter defibrillator, ICD, Telemedecine, Remote monitoring, Remote programming, Cardiac implantable electronical device, Medically underserved population, Medically underserved area
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 24 Apr 2023 (actual)
- Primary completion
- 2 Apr 2024 (actual)
- Study completion
- 2 Apr 2024 (actual)
- First posted
- 22 Feb 2024 (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.
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full CIED check-up and reprogramming is only possible when the patient visits a cardiologist capable of performing device programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. The aim of this study is to evaluate our previously validated remote programming solution (REACT study, NCT05366660) in outpatient device clinics which are close to the patient's home but remote from the CIED expert.
Detailed description
Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists and the possibility to offer expert support at remote locations or developing countries. Remote programming may be a way to mitigate disparities in health care access. The remote surveillance centre of CHU Bordeaux has previously developed and validated (REACT study, NCT05366660) a remote control system for CIED programmers that eliminates the physical presence of a cardiologist during the interrogation and programming process. The aim of this study is to evaluate this solution for the remote evaluation of CIEDs at the benefit of inhabitant of medically underserved population. Enrolled patients living >100km from the Bordeaux University Hospital will undergo there an in person evaluation of their CIED which will be compared six months later with a remote evaluation in a nurse office close to the patient's home.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective, single-center, single-arm, pairwise comparison trial
| Arm | Type | Receives |
|---|---|---|
| Teleconsultation | Experimental | Other: TeleconsultationTeleconsultation at 6 months |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient of both sexes over the age of 18
- Patients implanted with a cardiac pacemaker or an automatic defibrillator and an indication for device check-up (interrogation ± programming)
- Patient followed at the Bordeaux University Hospital but living more than 90km away
- Person beneficiary of social security insurance
- Informed consent confirmed in writing (at the latest on the day of inclusion and before any examination required by the research)
Key exclusion criteria (6 listed)
- Patients younger than 18 years old
- Patients who are incapable to understand the study design or to give informed consent.
- Pregnant or breastfeeding women
- Persons placed under legal protection
- Subject deprived of liberty on judicial or administrative decision
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 |
|---|---|---|
| TeleconsultationTeleconsultation at 6 months | Other | Teleconsultation |
Primary outcome
assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital
Time frame: 6 months
Patient satisfaction
4 secondary outcomes
Time saving for patient
Time frame: 6 months
Savings on medical transport
Time frame: 6 months
Costs associated with teleconsultation
Time frame: 6 months
safety of teleconsultation
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- Derived from this study: PubMed 39614866Ploux S, Strik M, Varma N, Bouteiller XP, Carlier L, Lissandreau S, Ben Boujema T, Boursier D, Hugot E, Haissaguerre M, Benali K, Bordachar P. Bridging the Gap: Remote Evaluation and Programming of Cardiac Implantable Devices in Medically Underserved Areas. JACC Clin Electrophysiol. 2025 Jan;11(1):171-178. doi: 10.1016/j.jacep.2024.09.027. Epub 2024 Nov 27.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Sylvain MD PLOUX principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Teleconsultation in people with Pacemaker and Defibrillator, run by University Hospital, Bordeaux at 1 site in France.
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 6 inclusion and 6 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: finished, as of the sponsor's last update on 17 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06272344, which also lists 1 linked publication.
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 17 Jun 2025; AzTrials last refreshed its copy on 30 Oct 2026.