Remote Programming of Cardiac Implantable Electronic Device
France110 participantsStarted 2021-06-08
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Successful remote interrogation and programming of CIED