Clinical trial NCT05366660: Remote Programming of Cardiac Implantable Electronic Device
Official title: Remote Programming of Cardiac Implantable Electronic Device
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Defibrillators, Implantable
Follow-Up Studies
Pacemaker, Artificial
Telemedicine
Algorithms
Keywords: Implantable cardioverter defibrillator
ICD
Pacemaker
Telemedicine
Remote monitoring
Cardiac implantable electronical device
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2022-05-09
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Multicenter feasibility study
Primary purpose: PREVENTION

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.

Detailed 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.

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) 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

Primary outcomes:
measure: Successful remote interrogation and programming of CIED
timeFrame: 18 months
Secondary outcomes:
measure: To assess the user-friendliness of the system (1)
timeFrame: 18 months
measure: To assess the user-friendliness of the system (2)
timeFrame: 18 months
measure: To assess the user-friendliness of the system (3)
timeFrame: 18 months
measure: To assess the user-friendliness of the system (4)
timeFrame: 18 months
Other outcomes:
Locations:
city: Pessac
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Sylvain MD Ploux
role: PRINCIPAL_INVESTIGATOR
References: