Remote Programming of Cardiac Implantable Electronic Devices 2
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pacemaker
- Sponsor
- University Hospital, Bordeaux
- Enrollment
- 36
- Locations
- 1
- Primary Endpoint
- assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital
- Status
- Completed
- Last Updated
- 10 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital
Time Frame: 6 months
Patient satisfaction
Secondary Outcomes
- Savings on medical transport(6 months)
- safety of teleconsultation(6 months)
- Time saving for patient(6 months)
- Costs associated with teleconsultation(6 months)