Remote Programming of Cardiac Implantable Electronic Device

Telemedicine Clinical Trial

— REACT  

Official title:

Remote Programming of Cardiac Implantable Electronic Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05366660
• Other study ID #: CHUBX 2021/07
• Status: Completed
• Phase: N/A
• Start date: June 8, 2021
• Est. completion date: April 4, 2022

Study information

• Verified date: January 2024
• Source: University Hospital, Bordeaux
• Contact: n/a
• 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 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.

Description:

Cardiac Implantable Electronic Devices (CIEDs) such as pacemakers and implantable cardioverter defibrillators, need to be regularly interrogated to guarantee proper functioning. In France, the follow-up of approximately 400 000 patients implanted with a CIED is performed by cardiologists. Remote monitoring allows for interrogation of contemporary CIEDs and has revolutionized the care for implanted patients. Early detection of arrhythmias, lead issues, battery depletion and algorithm side effects decreases both morbidity and mortality of CIED patients which is why today remote monitoring enjoys a class IA recommendation. While remote interrogation is advancing steadily, remote programming is not at all possible today. CIED problems may be quickly solved by changing the parameters but this is only possible when the patient visits a cardiologist capable of performing CIED programming. This can be challenging for patients and may cause unnecessary delays, particularly in settings of limited resources, enforced physical distancing, and quarantines. Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient, reduced need for presence of specialized cardiologists (in small clinics or diagnostic centers) and the possibility to offer expert support at remote locations or developing countries. At Bordeaux University, we have developed a method which enables remote programming of a CIED. The method requires the patient to be in direct vicinity of a CIED programmer, while the cardiologist specialized in CIED programming can operate the programmer from any remote location. We aim to investigate the efficacy and safety of remote programming by applying our method to implanted patients to perform remote interrogation and programming changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: April 4, 2022
• Est. primary completion date: April 4, 2022
• 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) 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.

• 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

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

Intervention

Other:
• Interrogation/programming
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.

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	Successful remote interrogation and programming of CIED	Success rate of remote interrogation and programming of CIED	18 months
Secondary	To assess the user-friendliness of the system (1)	Time of the procedure (interrogation and programming)	18 months
Secondary	To assess the user-friendliness of the system (2)	Type of programming modifications done	18 months
Secondary	To assess the user-friendliness of the system (3)	Time of intallation procedure	18 months
Secondary	To assess the user-friendliness of the system (4)	Turnaround time of the command	18 months