Evaluation of Left Ventricular Filling Pressure in CardiologyESTIM LVFPNCT07619196
Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple Watch and 12-Lead ECG Optimized by an Artificial Intelligence Algorithm
An observational study of Evaluation of Left Ventricular Filling Pressure in Cardiology, run by RCF@ICPS at 1 site in France.
Trial summary
Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Evaluation of Left Ventricular Filling Pressure in Cardiology
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2024to 30 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: In this trial, 200 patients will be recruited at the Jacques Cartier private hospital, Massy (France).
Who may be able to join
- 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
Who cannot join
- 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
- Patient with significant degenerative mitral annular calcification (MAC)
- Subject related to the investigator or any other staff member directly involved in the clinical investigation
- Patient unable to give consent, minor patient, or legally protected adult patient
Trial locations and contacts
1 site in 1 country.
France1 site
Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud
Massy, 91300
About this study
Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)
Measured: Day 1
Secondary outcomes (2)
Secondary endpoints
Comparison of the performance of the IA-AW and IA-12D in detecting elevated filling pressures in mmHG, compared to the diagnosis of conventional transthoracic echocardiography (TTE)
Measured: Day 1
Secondary endpoints
Classification of filling pressures (elevated, normal, indeterminate) in mmHG by the IA-AW and IA-12D, compared to the diagnosis of conventional transthoracic echocardiography (TTE)
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start9 Jul 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Evaluation of Left Ventricular Filling Pressure in CardiologyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- RCF@ICPS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Laurent FIORINA, MD, Principal investigator, RCF@ICPS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619196
- Sponsor's protocol ID
- 24.02225.000449
- Acronym
- ESTIM LVFP
- Status last verified
- May 2026
- First submitted
- 20 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple Watch and 12-Lead ECG Optimized by an Artificial Intelligence Algorithm
- ClinicalTrials.gov ID
- NCT07619196
- Acronym / sponsor ID
- ESTIM LVFP / 24.02225.000449
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- RCF@ICPSUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- In this trial, 200 patients will be recruited at the Jacques Cartier private hospital, Massy (France).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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
- Patient with significant degenerative mitral annular calcification (MAC)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Primary endpoint
Time frame: Day 1
Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)
2 secondary outcomes
Secondary endpoints
Time frame: Day 1
Secondary endpoints
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laurent FIORINA, MD principal investigator
RCF@ICPS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of Left Ventricular Filling Pressure in Cardiology, run by RCF@ICPS at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.