Connected Cardiology to Control Cardiac Rythm

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 :

Our hypothesis is that CardiacSense Medical System is an effective, safe, and better accepted alternative for detecting atrial fibrillation (AF) in a high-risk population than implantable loop recorders (ILRs).

Population :

Any patient aged 18 years or more, with an ILR implanted for the detection of AF will be eligible. The time of implantation will not matter as long as the batteries work. Each patient will be proposed a CS Medical Watch for a period corresponding to the period at risk of AF.

Main objective :

To compare the performance of the CardiacSense Medical Watch by pulse plethysmography (PPG) only to the gold standard method of ILR monitoring, to detect AF that lasts 5 minutes or more, in a population of patients at high risk of paroxysmal AF.

Inclusion criteria

• 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 criteria

• 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.