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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07619196

Acronym

ESTIM LVFP

Enrollment

200

Registered

2026-06-01

Start date

2024-07-09

Completion date

2025-04-30

Last updated

2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Evaluation of Left Ventricular Filling Pressure in Cardiology

Brief summary

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Secondary endpoints	Day 1	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)

Countries

France

Contacts

PRINCIPAL_INVESTIGATORLaurent FIORINA, MD

RCF@ICPS

Outcome results