Telemedicine Clinical Trial
— REACTOfficial title:
Remote Programming of Cardiac Implantable Electronic Device
Verified date | January 2024 |
Source | University Hospital, Bordeaux |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 110 |
Est. completion date | April 4, 2022 |
Est. primary completion date | April 4, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
France | Bordeaux University Hospital | Pessac |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Bordeaux |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Successful remote interrogation and programming of CIED | Success rate of remote interrogation and programming of CIED | 18 months | |
Secondary | To assess the user-friendliness of the system (1) | Time of the procedure (interrogation and programming) | 18 months | |
Secondary | To assess the user-friendliness of the system (2) | Type of programming modifications done | 18 months | |
Secondary | To assess the user-friendliness of the system (3) | Time of intallation procedure | 18 months | |
Secondary | To assess the user-friendliness of the system (4) | Turnaround time of the command | 18 months |
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