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Completed

NCT Number: NCT06272344

Remote Programming of Cardiac Implantable Electronic Devices 2

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bordeaux University Hospital

Pessac, France, 33604

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Teleconsultation

Other

Teleconsultation at 6 months

Primary outcomes

  1. assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital

    Time frame: 6 months

    Patient satisfaction

Secondary outcomes

  1. Time saving for patient

    Time frame: 6 months

    Time of consultation and teleconsultation

  2. Savings on medical transport

    Time frame: 6 months

    Cost of medical transports for consultation and teleconsultation

  3. Costs associated with teleconsultation

    Time frame: 6 months

    Global amount of costs for teleconsultation

  4. safety of teleconsultation

    Time frame: 6 months

    Number of Adverse Events and technical incidents

Sponsors and collaborators

Lead sponsor

University Hospital, Bordeaux

Other

Registry information

Acronym: REACT 2

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 22, 2024
Registry last updated
Jun 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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