Remote Programming of Cardiac Implantable Electronic Devices 2 (REACT 2)

University Hospital of Bordeaux

Status

Completed

Conditions

Telemedecine

Pacemaker

Defibrillator

Treatments

Other: Teleconsultation

Study type

Interventional

Funder types

Other

Identifiers

NCT06272344

CHUBX 2022/38

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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