Connected Cardiology to Control Cardiac Rythm

N/ANot Yet RecruitingNCT06091514

Assistance Publique - Hôpitaux de Paris400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring

The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring using the CardiacSense Medical Watch by pulse plethysmography (PPG) only vs the gold standard method of ILR ECG recording, over the same period of monitoring by the two devices for each patient.