Remote Programming of Cardiac Implantable Electronic Devices 2

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-04-24

Study Completion Date

2024-04-02

Brief Summary

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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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Detailed Description

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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

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Pacemaker Defibrillator Telemedecine

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective, single-center, single-arm, pairwise comparison trial

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Teleconsultation

Teleconsultation at 6 months

Group Type EXPERIMENTAL

Teleconsultation

Intervention Type OTHER

Teleconsultation at 6 months

Interventions

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Teleconsultation

Teleconsultation at 6 months

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No