NCT06091514Withdrawn
Connected Cardiology to Control Cardiac Rythm
Source: ClinicalTrials.gov · Last updated 25 Aug 2026
Reason given: Decision by the manufacturer
Brief summary (registry, in English)
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.
- Status (registry)
- Withdrawn
- Study type
- Interventional
- Enrollment
- 0 (actual)
- First submitted
- 16 Oct 2023
- Start date
- Feb 2024
- Primary completion date
- Feb 2026
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Atrial fibrillation
- NCT number
- NCT06091514
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patient with blood flow deficiency-related conditions
Other
- Patient under legal protection
- Pregnant and/or breastfeeding women
- Patient with pacemakers, or ICD
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.