Connected Cardiology to Control Cardiac Rythm (NCT06091514) | Clinical Trial Compass
UnknownNot Applicable
Connected Cardiology to Control Cardiac Rythm
400 participantsStarted 2024-09
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The total number of episodes AF that lasts 5 min or more recorded on long-term monitoring
Timeframe: between 3 and 12 months according to the period at risk of AF