NCT06272344

Remote Programming of Cardiac Implantable Electronic Devices 2

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University Hospital, Bordeaux · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Pacemaker
• Defibrillator
• Telemedecine

Interventions

Type	Name	Description
OTHER	Teleconsultation	Teleconsultation at 6 months

Timeline

• Start date: 2023-04-24
• Primary completion: 2024-04-02
• Completion: 2024-04-02
• First posted: 2024-02-22
• Last updated: 2025-06-17

Locations

1 site across 1 country: France