Clinical trial NCT06272344: Remote Programming of Cardiac Implantable Electronic Devices 2
Official title: Remote Programming of Cardiac Implantable Electronic Devices 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pacemaker
Defibrillator
Telemedecine
Keywords: Implantable cardioverter defibrillator
ICD
Telemedecine
Remote monitoring
Remote programming
Cardiac implantable electronical device
Medically underserved population
Medically underserved area
Health professional shortage area
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single-center, single-arm, pairwise comparison trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital
timeFrame: 6 months
Secondary outcomes:
measure: Time saving for patient
timeFrame: 6 months
measure: Savings on medical transport
timeFrame: 6 months
measure: Costs associated with teleconsultation
timeFrame: 6 months
measure: safety of teleconsultation
timeFrame: 6 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Sylvain MD PLOUX
role: PRINCIPAL_INVESTIGATOR
References: