Observational Clinical Study for the Evaluation of Left Ventricular Filling Pressures Using Apple Watch and 12-Lead ECG Optimized by an Artificial Intelligence Algorithm (ESTIM LVFP)

Observational, non-interventional, prospective, open-label, single-center, non-randomized study of a CE-marked medical device used in its intended purpose.

Study Overview

• Status: Completed
• Conditions: Evaluation of Left Ventricular Filling Pressure in Cardiology

• Study Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• France
  • Massy, France, 91300
    • Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

In this trial, 200 patients will be recruited at the Jacques Cartier private hospital, Massy (France).

Description

Inclusion Criteria:

1. Patient aged 18 years or older, capable of providing informed consent and wishing to participate in the clinical investigation
2. Patient referred outpatient for a conventional echocardiogram
3. 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
4. Emergency department patient referred for a conventional echocardiogram
5. 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
6. Patient covered by a social security scheme

Exclusion Criteria:

1. Patient with complex congenital heart disease
2. Heart transplant recipient
3. Patient with a history of mitral valve surgery (mechanical valve, bioprosthesis, annuloplasty)
4. Patient with a pacemaker/defibrillator
5. Patient with significant degenerative mitral annular calcification (MAC)
6. Subject related to the investigator or any other staff member directly involved in the clinical investigation
7. Patient unable to give consent, minor patient, or legally protected adult patient

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary endpoint	Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)	Day 1

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	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)	Day 1

Collaborators and Investigators

• Sponsor: RCF@ICPS
• Investigators: Principal Investigator: Laurent FIORINA, MD, RCF@ICPS

Study record dates

Study Major Dates

• Study Start (Actual): July 9, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: May 20, 2026
• First Submitted That Met QC Criteria: May 27, 2026
• First Posted (Actual): June 1, 2026

Study Record Updates

• Last Update Posted (Actual): June 1, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 24.02225.000449

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No