Pacemaker Clinical Trial
— REACT 2Official title:
Remote Programming of Cardiac Implantable Electronic Devices 2
Verified date | May 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 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.
Status | Completed |
Enrollment | 36 |
Est. completion date | April 2, 2024 |
Est. primary completion date | April 2, 2024 |
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) - Patient followed at the Bordeaux University Hospital but living more than 90km away - 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 legal protection - 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 | assess the satisfaction of patients benefiting from a teleconsultation compared to a standard consultation at hospital | Patient satisfaction | 6 months | |
Secondary | Time saving for patient | Time of consultation and teleconsultation | 6 months | |
Secondary | Savings on medical transport | Cost of medical transports for consultation and teleconsultation | 6 months | |
Secondary | Costs associated with teleconsultation | Global amount of costs for teleconsultation | 6 months | |
Secondary | safety of teleconsultation | Number of Adverse Events and technical incidents | 6 months |
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