Remote Programming of Cardiac Implantable Electronic Device

NCT05366660 | Completed

• 1 other identifier: CHUBX 2021/07
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief Summary

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated and reprogrammed to ensure proper functioning. While remote monitoring allows for partial interrogation at a remote location, full interrogation and changing the CIED parameters 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. We aim to investigate the efficacy and safety of remote programming.

Conditions

Defibrillators, Implantable; Follow-Up Studies; Pacemaker, Artificial; Telemedicine; Algorithms

Keywords

Implantable cardioverter defibrillator; ICD; Pacemaker; Telemedicine; Remote monitoring; Cardiac implantable electronical device

Outcome Measures

Primary Outcomes (1)

• Successful remote interrogation and programming of CIED

  Success rate of remote interrogation and programming of CIED

  18 months

Secondary Outcomes (4)

• To assess the user-friendliness of the system (1)

  18 months

• To assess the user-friendliness of the system (2)

  18 months

• To assess the user-friendliness of the system (3)

  18 months

• To assess the user-friendliness of the system (4)

  18 months

Study Arms (1)

CIED's interrogation/programming

EXPERIMENTAL

All the patients will be included in this single arm to interrogate/programm their CIED

Other: Interrogation/programming

Interventions

Interrogation/programming OTHER

As the study investigates remote programming, we will describe two locations: local (patient side) and remote (expert side). Local support is defined by a physician or a technician under the direct responsibility of a nearby physician who connect the patient to the remote programming system. Similar to a conventional check-up, an external defibrillator will be located in the near vicinity of the patient. The patient will first be connected to the programmer as during a conventional follow-up. The programmer will then be connected to a local PC which captures the programmer VGA video output and controls the programmer through a mouse emulator. This local PC will be remotely controlled by the remote PC using Cisco Webex, a communication software used worldwide to support telemedicine.

CIED's interrogation/programming

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) which may be periodic as part of their follow-up, postoperative, following a remote monitoring alert, pre/post MRI or following symptoms.
• 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 judicial protection, curatorship, tutorship.
• 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

Study Officials

• Sylvain MD Ploux

  University Hospital, Bordeaux

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Multicenter feasibility study

Study Record Dates

• First Submitted: May 5, 2022
• First Posted: May 9, 2022
• Study Start: June 8, 2021
• Primary Completion: April 4, 2022
• Study Completion: April 4, 2022
• Last Updated: June 17, 2025

Record last verified: 2025-06

Locations

FR (1)