Ignite Creation Date:
2024-05-06 @ 8:09 PM
Last Modification Date:
2024-10-26 @ 3:21 PM
Study NCT ID:
NCT06272344
Status:
COMPLETED
Last Update Posted:
2024-05-17
First Post:
2024-02-15
Brief Title:
Remote Programming of Cardiac Implantable Electronic Devices 2
Sponsor:
University Hospital Bordeaux
Organization:
University Hospital Bordeaux
Study Overview
Official Title:
Remote Programming of Cardiac Implantable Electronic Devices 2
Status:
COMPLETED
Status Verified Date:
2024-05
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 2
Brief Summary:
Cardiac Implantable Electronic Devices CIEDs such as pacemakers and implantable cardioverter defibrillators need to be regularly and systematically interrogated and reprogrammed to ensure proper functioning While remote monitoring allows for partial interrogation at a remote location full CIED check-up and reprogramming 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 The aim of this study is to evaluate our previously validated remote programming solution REACT study NCT05366660 in outpatient device clinics which are close to the patients home but remote from the CIED expert
Detailed Description:
Remote programming of a CIED offers multiple advantages such as shorter travel distances for the patient reduced need for presence of specialized cardiologists and the possibility to offer expert support at remote locations or developing countries Remote programming may be a way to mitigate disparities in health care access The remote surveillance centre of CHU Bordeaux has previously developed and validated REACT study NCT05366660 a remote control system for CIED programmers that eliminates the physical presence of a cardiologist during the interrogation and programming process The aim of this study is to evaluate this solution for the remote evaluation of CIEDs at the benefit of inhabitant of medically underserved population Enrolled patients living 100km from the Bordeaux University Hospital will undergo there an in person evaluation of their CIED which will be compared six months later with a remote evaluation in a nurse office close to the patients home
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None