Remote Programming of Cardiac Implantable Electronic Devices 2

NCT06272344 | Completed

• 1 other identifier: CHUBX 2022/38
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital

  Patient satisfaction

  6 months

Secondary Outcomes (4)

• Time saving for patient

  6 months

• Savings on medical transport

  6 months

• Costs associated with teleconsultation

  6 months

• safety of teleconsultation

  6 months

Study Arms (1)

Teleconsultation

EXPERIMENTAL

Teleconsultation at 6 months

Other: Teleconsultation

Interventions

Teleconsultation OTHER

Teleconsultation at 6 months

Teleconsultation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Women of procreating age with effective contraception

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Bordeaux University Hospital

Pessac, France, 33604, France

Location

Related Publications (1)

• Ploux S, Strik M, Varma N, Bouteiller XP, Carlier L, Lissandreau S, Ben Boujema T, Boursier D, Hugot E, Haissaguerre M, Benali K, Bordachar P. Bridging the Gap: Remote Evaluation and Programming of Cardiac Implantable Devices in Medically Underserved Areas. JACC Clin Electrophysiol. 2025 Jan;11(1):171-178. doi: 10.1016/j.jacep.2024.09.027. Epub 2024 Nov 27.

  PMID: 39614866 DERIVED

MeSH Terms

Interventions

Remote Consultation

Intervention Hierarchy (Ancestors)

Referral and Consultation; Professional Practice; Organization and Administration; Health Services Administration; Telemedicine; Delivery of Health Care; Patient Care Management

Study Officials

• Sylvain MD PLOUX

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective, single-center, single-arm, pairwise comparison trial

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: February 22, 2024
• Study Start: April 24, 2023
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: June 17, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)