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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 patient's home but remote from the CIED expert.
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 patient's home.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teleconsultation | Experimental | Teleconsultation at 6 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teleconsultation | Other | Teleconsultation at 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital | Patient satisfaction | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time saving for patient | Time of consultation and teleconsultation | 6 months |
| Savings on medical transport | Cost of medical transports for consultation and teleconsultation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvain MD PLOUX | University Hospital, Bordeaux | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux University Hospital | Pessac | France | 33604 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39614866 | Derived | Ploux S, Strik M, Varma N, Bouteiller XP, Carlier L, Lissandreau S, Ben Boujema T, Boursier D, Hugot E, Haissaguerre M, Benali K, Bordachar P. Bridging the Gap: Remote Evaluation and Programming of Cardiac Implantable Devices in Medically Underserved Areas. JACC Clin Electrophysiol. 2025 Jan;11(1):171-178. doi: 10.1016/j.jacep.2024.09.027. Epub 2024 Nov 27. |
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| ID | Term |
|---|---|
| D019114 | Remote Consultation |
| ID | Term |
|---|---|
| D012017 | Referral and Consultation |
| D011364 | Professional Practice |
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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Prospective, single-center, single-arm, pairwise comparison trial
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| 6 months |
| Costs associated with teleconsultation | Global amount of costs for teleconsultation | 6 months |
| safety of teleconsultation | Number of Adverse Events and technical incidents | 6 months |
| D017216 | Telemedicine |
| D003695 | Delivery of Health Care |
| D010346 | Patient Care Management |