Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple… (NCT07619196) | Clinical Trial Compass
CompletedNot Applicable
Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple Watch and 12-Lead ECG Optimized by an Artificial Intelligence Algorithm
France200 participantsStarted 2024-07-09
Plain-language summary
Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
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 older, capable of providing informed consent and wishing to participate in the clinical investigation
. Patient referred outpatient for a conventional echocardiogram
. Patient hospitalized in a medical or surgical unit, including the cardiac intensive care unit and the cardiac surgery postoperative unit, and referred for a conventional echocardiogram
. Emergency department patient referred for a conventional echocardiogram
. Patient who has read the information leaflet and given their written consent to participate by dating and signing the informed consent form before any procedure related to the clinical investigation
. Patient covered by a social security scheme
Exclusion criteria
. Patient with complex congenital heart disease
. Heart transplant recipient
. Patient with a history of mitral valve surgery (mechanical valve, bioprosthesis, annuloplasty)
. Patient with a pacemaker/defibrillator
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.