Remote Programming of Cardiac Implantable Electronic Device

Phase

N/A

Condition

N/A

Treatment

Interrogation/programming

Clinical Study ID

NCT05366660

CHUBX 2021/07

2021-A00885-36

Ages > 18
All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Patient of both sexes over the age of 18
Patients implanted with a cardiac pacemaker or an automatic defibrillator and anindication for device check-up (interrogation ± programming) which may be periodicas 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 andbefore any examination required by the research).
Women of procreating age with effective contraception

Exclusion

Exclusion Criteria:

Patients younger than 18 years old
Patients who are incapable to understand the study design or to give informedconsent.
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

Study Design

Interrogation/programming

June 08, 2021

April 04, 2022

Study 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.

Connect with a study center

Bordeaux University Hospital
Pessac, France 33604
France
Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.