NCT06091514

Connected Cardiology to Control Cardiac Rythm

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Assistance Publique - Hôpitaux de Paris · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 detection in high risk populations such as patients with a recent stroke or TIA or, symptomatic patients with multiple risk factors for AF, is performed with long-term electrocardiography monitoring using frequently implantable loop recorders (ILR). These recorders have their own limitations related to the invasive nature of the device implanted under the skin of the chest with limited acceptation by the patients. Smart watches appear as useful alternatives, but they need to be evaluated in an all-comer population of patients highly exposed to AF, different from the large population studies conducted in healthy young adults with a low incidence of AF. The unique features of CardiacSense Medical System suggest that we could have an accurate noninvasive detection of AF in a selected population very much exposed to the risk of atrial fibrillation, the most frequent atrial arrhythmia.

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 : 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.

Conditions

• Atrial Fibrillation

Interventions

Type	Name	Description
DEVICE	CS Medical Watch	The Use of the CS Medical Watch during the participation period of the clinical investigation (between 3 and 12 months according to the period at risk of AF).
OTHER	Specific questionnaire	Specific questionnaire during the last study visit (takes place at M3 to M12 according to the period at risk of AF)

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-02-01
• Completion: 2026-02-01
• First posted: 2023-10-19
• Last updated: 2024-07-31