Remote Programming of Cardiac Implantable Electronic Devices 2

Pacemaker Clinical Trial

— REACT 2  

Official title:

Remote Programming of Cardiac Implantable Electronic Devices 2

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06272344
• Other study ID #: CHUBX 2022/38
• Status: Recruiting
• Phase: N/A
• Start date: April 24, 2023
• Est. completion date: October 24, 2024

Study information

• Verified date: February 2024
• Source: University Hospital, Bordeaux
• Contact: Sylvain PLOUX, MD
• Phone: (0)5 57 65 64 71
• Email: sylvain.ploux[@]chu-bordeaux.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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. In this study we aim 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.

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. We have 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. In this study we aim 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 their home.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 24, 2024
• Est. primary completion date: October 24, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 judicial protection, curatorship, tutorship.
• Subject deprived of liberty on judicial or administrative decision
• Persons participating in another study who are still in their period of exclusion

Related Conditions & MeSH terms

• Defibrillator
• Pacemaker

Intervention

Other:
• Teleconsultation
Teleconsultation at 6 months

Locations

Country	Name	City	State
France	Bordeaux University Hospital	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital	Patient satisfaction	6 months
Secondary	Time saving for patient	Time of consultation and teleconsultation	6 months
Secondary	Savings on medical transport	Cost of medical transports for consultation and teleconsultation	6 months
Secondary	Costs associated with teleconsultation	Global amount of costs for teleconsultation	6 months
Secondary	safety of teleconsultation	Number of EI and technical incidents	6 months