Status:
NOT_YET_RECRUITING
Connected Cardiology to Control Cardiac Rythm
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Action Research Group
Hôpital Lariboisière Fernand Widal
Conditions:
Atrial Fibrillation
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
New-onset of atrial fibrillation (AF) and atrial arrythmia (AA) in general, is important as it exposes patients to stroke or other embolic complications not to mention the risk of heart failure. AF de...
Detailed Description
Study design : This clinical investigation is a comparative, non-randomised, one group, controlled study. Each patient represents its own control. The study will envolve 400 participants Hypothesis...
Eligibility Criteria
Inclusion
- Patient aged 18 years or more
- Patient having signed free, informed, and written consent
- Patient presenting one of the following situations :
- Post-stroke or TIA patient with an already in place ILR
- Patient with symptoms evocative of AF (e.g. increased heart rate, chest pain) with an already in place ILR
- Post-PFO closure patient with an already in place ILR
- Patient in sinus rhythm treated for the prevention of paroxysmal AF with an already in place ILR
- Patient at high risk of AF (at the discretion of the investigator) with an already in place ILR
- Patient with a period of risk of AF ≥ 3 months.
Exclusion
- Patient under legal protection
- Pregnant and/or breastfeeding women
- Patient with pacemakers, or ICD
- Patient with blood flow deficiency-related conditions
- Patient with tattoo or injured skin on the wrist
- Patient with tremors or otherwise unable to remain still for 15 minutes
- Patient without two hands and sufficient fingers to complete the study.
Key Trial Info
Start Date :
September 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2026
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06091514
Start Date
September 1 2024
End Date
February 1 2026
Last Update
July 31 2024
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