Defibrillators, ImplantableREACTNCT05366660
Remote Programming of Cardiac Implantable Electronic Device
A study testing Interrogation/programming in people with Defibrillators, Implantable and Follow-Up Studies, 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 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
- Defibrillators, Implantable, Follow-Up Studies, Pacemaker, Artificial
- What is being tested?
- Interrogation/programming
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteFrance
- Study dates
- 8 Jun 2021to 4 Apr 2022
- 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) which may be periodic as part of their follow-up, postoperative, following a remote monitoring alert, pre/post MRI or following symptoms.
- 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 judicial protection, curatorship, tutorship.
- 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 interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters 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. We aim to investigate the efficacy and safety of remote programming.
Read the detailed description
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated to guarantee proper functioning. In France, the follow-up of approximately 400 000 patients implanted with a CIED is performed by cardiologists. Remote monitoring allows for interrogation of contemporary CIEDs and has revolutionized the care for implanted patients. Early detection of arrhythmias, lead issues, battery depletion and algorithm side effects decreases both morbidity and mortality of CIED patients which is why today remote monitoring enjoys a class IA recommendation. While remote interrogation is advancing steadily, remote programming is not at all possible today. CIED problems may be quickly solved by changing the parameters but this is only possible when the patient visits a cardiologist capable of performing CIED programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists (in small clinics or diagnostic centers) and the possibility to offer expert support at remote locations or developing countries. At Bordeaux University, we have developed a method which enables remote programming of a CIED. The method requires the patient to be in direct vicinity of a CIED programmer, while the cardiologist specialized in CIED programming can operate the programmer from any remote location. We aim to investigate the efficacy and safety of remote programming by applying our method to implanted patients to perform remote interrogation and programming changes.
- Conditions
- Defibrillators, Implantable, Follow-Up Studies, Pacemaker, Artificial, Telemedicine, Algorithms
- Being tested
- Interrogation/programming
- Keywords
- Implantable cardioverter defibrillator, ICD, Pacemaker, Telemedicine, Remote monitoring, Cardiac implantable electronical device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interrogation/programmingOther
As the study investigates remote programming, we will describe two locations: local (patient side) and remote (expert side). Local support is defined by a physician or a technician under the direct responsibility of a nearby physician who connect the patient to the remote programming system. Similar to a conventional check-up, an external defibrillator will be located in the near vicinity of the patient. The patient will first be connected to the programmer as during a conventional follow-up. The programmer will then be connected to a local PC which captures the programmer VGA video output and controls the programmer through a mouse emulator. This local PC will be remotely controlled by the remote PC using Cisco Webex, a communication software used worldwide to support telemedicine.
| Study group | Role | What they receive |
|---|---|---|
| CIED's interrogation/programming | Experimental | All the patients will be included in this single arm to interrogate/programm their CIED Receives: Other: Interrogation/programming |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful remote interrogation and programming of CIED
Success rate of remote interrogation and programming of CIED
Measured: 18 months
Secondary outcomes (4)
To assess the user-friendliness of the system (1)
Time of the procedure (interrogation and programming)
Measured: 18 months
To assess the user-friendliness of the system (2)
Type of programming modifications done
Measured: 18 months
To assess the user-friendliness of the system (3)
Time of intallation procedure
Measured: 18 months
To assess the user-friendliness of the system (4)
Turnaround time of the command
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2022
- Study start8 Jun 2021
- Primary completion4 Apr 2022
- Study completion4 Apr 2022
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 Defibrillators, ImplantableStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter feasibility study
- Masking
- None (open label)
- Enrolment
- 110 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
- NCT05366660
- Sponsor's protocol ID
- CHUBX 2021/07
- Other IDs
- 2021-A00885-36
- Acronym
- REACT
- Status last verified
- Jun 2025
- First submitted
- 5 May 2022
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ploux S, Strik M, Demoniere F, Rakotoarimanana D, Zemmoura A, Deplagne A, Haissaguerre M, Varma N, Bordachar P. Remote interrogation and reprogramming of cardiac implantable electronic devices using a custom multivendor solution. Heart Rhythm. 2023 Apr;20(4):547-551. doi: 10.1016/j.hrthm.2022.12.015. Epub 2022 Dec 13.
PubMed 36526165
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remote Programming of Cardiac Implantable Electronic Device
- ClinicalTrials.gov ID
- NCT05366660
- Acronym / sponsor ID
- REACT / CHUBX 2021/07
- Conditions
- Defibrillators, Implantable, Follow-Up Studies, Pacemaker, Artificial, Telemedicine, Algorithms
- Keywords
- Implantable cardioverter defibrillator, ICD, Pacemaker, Telemedicine, Remote monitoring, Cardiac implantable electronical device
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 8 Jun 2021 (actual)
- Primary completion
- 4 Apr 2022 (actual)
- Study completion
- 4 Apr 2022 (actual)
- First posted
- 9 May 2022 (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 interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters 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. We aim to investigate the efficacy and safety of remote programming.
Detailed description
Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated to guarantee proper functioning. In France, the follow-up of approximately 400 000 patients implanted with a CIED is performed by cardiologists. Remote monitoring allows for interrogation of contemporary CIEDs and has revolutionized the care for implanted patients. Early detection of arrhythmias, lead issues, battery depletion and algorithm side effects decreases both morbidity and mortality of CIED patients which is why today remote monitoring enjoys a class IA recommendation. While remote interrogation is advancing steadily, remote programming is not at all possible today. CIED problems may be quickly solved by changing the parameters but this is only possible when the patient visits a cardiologist capable of performing CIED programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists (in small clinics or diagnostic centers) and the possibility to offer expert support at remote locations or developing countries. At Bordeaux University, we have developed a method which enables remote programming of a CIED. The method requires the patient to be in direct vicinity of a CIED programmer, while the cardiologist specialized in CIED programming can operate the programmer from any remote location. We aim to investigate the efficacy and safety of remote programming by applying our method to implanted patients to perform remote interrogation and programming changes.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter feasibility study
| Arm | Type | Receives |
|---|---|---|
| CIED's interrogation/programming | Experimental | Other: Interrogation/programmingAll the patients will be included in this single arm to interrogate/programm their CIED |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 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) which may be periodic as part of their follow-up, postoperative, following a remote monitoring alert, pre/post MRI or following symptoms.
- 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
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 judicial protection, curatorship, tutorship.
- 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 |
|---|---|---|
| Interrogation/programmingAs the study investigates remote programming, we will describe two locations: local (patient side) and remote (expert side). Local support is defined by a physician or a technician under the direct responsibility of a nearby physician who connect the patient to the remote programming system. Similar to a conventional check-up, an external defibrillator will be located in the near vicinity of the patient. The patient will first be connected to the programmer as during a conventional follow-up. The programmer will then be connected to a local PC which captures the programmer VGA video output and controls the programmer through a mouse emulator. This local PC will be remotely controlled by the remote PC using Cisco Webex, a communication software used worldwide to support telemedicine. | Other | CIED's interrogation/programming |
Primary outcome
Successful remote interrogation and programming of CIED
Time frame: 18 months
Success rate of remote interrogation and programming of CIED
4 secondary outcomes
To assess the user-friendliness of the system (1)
Time frame: 18 months
To assess the user-friendliness of the system (2)
Time frame: 18 months
To assess the user-friendliness of the system (3)
Time frame: 18 months
To assess the user-friendliness of the system (4)
Time frame: 18 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 14 May 2026.
- Results publication: PubMed 36526165Ploux S, Strik M, Demoniere F, Rakotoarimanana D, Zemmoura A, Deplagne A, Haissaguerre M, Varma N, Bordachar P. Remote interrogation and reprogramming of cardiac implantable electronic devices using a custom multivendor solution. Heart Rhythm. 2023 Apr;20(4):547-551. doi: 10.1016/j.hrthm.2022.12.015. Epub 2022 Dec 13.
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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 Interrogation/programming in people with Defibrillators, Implantable and Follow-Up Studies, 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 5 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 14 May 2026. 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?
Successful remote interrogation and programming of CIED (time frame: 18 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 NCT05366660, 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 14 May 2026.