Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2025-12-26 @ 4:29 PM
Study NCT ID:
NCT05366660
Status:
COMPLETED
Last Update Posted:
2025-06-17
First Post:
2022-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Remote Programming of Cardiac Implantable Electronic Device
Sponsor:
University Hospital, Bordeaux
Organization:
Study Overview
Official Title:
Remote Programming of Cardiac Implantable Electronic Device
Status:
COMPLETED
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
REACT
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: