NCT06091514Visszavonva
Connected Cardiology to Control Cardiac Rythm
Forrás: ClinicalTrials.gov · Utoljára frissítve: 2026. aug. 25.
Megadott ok: Decision by the manufacturer
Rövid összefoglaló (regiszter, angolul)
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.
- Állapot (regiszter)
- Visszavonva
- Vizsgálattípus
- Beavatkozással járó
- Résztvevők száma
- 0 (tényleges)
- Első benyújtás
- 2023. okt. 16.
- Kezdés
- 2024. febr.
- Elsődleges befejezés
- 2026. febr.
- Fő szponzor
- Assistance Publique - Hôpitaux de Paris
- Betegségek
- Pitvarfibrilláció
- NCT-szám
- NCT06091514
Ki nem vehet részt
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Más betegség
- Patient with blood flow deficiency-related conditions
Egyéb
- 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.
Kiket keres a vizsgálat
- 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.
Életkor a regiszterben: 18 év – - · Nem: nők és férfiak · Egészséges önkénteseket nem fogad
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