Remote Programming of Cardiac Implantable Electronic Devices 2 (REACT 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.

Study Overview

• Status: Completed
• Conditions: Pacemaker; Defibrillator; Telemedecine
• Intervention / Treatment: Other: Teleconsultation

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 Type: Interventional
• Enrollment (Actual): 36
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Pessac, France, 33604
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teleconsultation; Teleconsultation at 6 months	Other: Teleconsultation; Teleconsultation at 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital	Patient satisfaction	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time saving for patient	Time of consultation and teleconsultation	6 months
Savings on medical transport	Cost of medical transports for consultation and teleconsultation	6 months
Costs associated with teleconsultation	Global amount of costs for teleconsultation	6 months
safety of teleconsultation	Number of Adverse Events and technical incidents	6 months

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Sylvain MD Ploux, University Hospital, Bordeaux

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2023
• Primary Completion (Actual): April 2, 2024
• Study Completion (Actual): April 2, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 15, 2024
• First Posted (Actual): February 22, 2024

Study Record Updates

• Last Update Posted (Actual): June 17, 2025
• Last Update Submitted That Met QC Criteria: June 12, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: ICD; Remote monitoring; Telemedecine; Implantable cardioverter defibrillator; Cardiac implantable electronical device; Medically underserved area; Medically underserved population; Remote programming; Health professional shortage area
• Other Study ID Numbers: CHUBX 2022/38

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
• product manufactured in and exported from the U.S.: No