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

NCT07619196 | Completed

• 1 other identifier: 24.02225.000449
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Evaluation of Left Ventricular Filling Pressure in Cardiology

Outcome Measures

Primary Outcomes (1)

• Primary endpoint

  Detection of elevated filling pressures in mmHG by IA-AW, compared to diagnosis by conventional transthoracic echocardiography (TTE)

  Day 1

Secondary Outcomes (2)

• Secondary endpoints

  Day 1

• Secondary endpoints

  Day 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• RCF@ICPS: lead

Study Sites (1)

Hôpital Privé Jacques Cartier, Institut Cardiovasculaire Paris Sud

Massy, 91300, France

Location

Study Officials

• Laurent FIORINA, MD

  RCF@ICPS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2026
• First Posted: June 1, 2026
• Study Start: July 9, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

FR (1)