Using AI to Measure Heart Pressure Non-Invasively

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to validate an artificial intelligence software that estimates left ventricular filling pressure (LVFP) non-invasively through echocardiography. The study will compare the AI-generated estimates with those obtained from invasive methods like left and right heart catheterization. Additionally, it will assess the software's effectiveness in detecting elevated left ventricular end-diastolic pressure (LVEDP) compared to existing algorithms. The study will involve patients who can provide high-quality echocardiographic images of the left atrium.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* ≥ 18 yo,
* Signed informed consent to be part of this study,
* No pregnancy,
* Good acoustic window and patient cooperation to obtain good 2- and 3-dimensional datasets focused on left atrium (LA),

Exclusion Criteria:

* Unwillingness to be part of the study,
* Patients with poor 2-dimensional imaging quality in ≥ 1 LA segment or lacking of a discernible R-R interval, which might preclude accurate strain measurements,
* Patients with more than mild mitral valve heart disease, aortic regurgitation, left side valvular prosthesis or mitral valve repair, mitral annulus calcification (≥ 5 mm),
* Patients with history or presence of atrial fibrillation (AF), supraventricular arrhythmias, ventricular paced rhythm, left bundle branch block (LBBB),
* Patients taking diuretics or vasodilators (nitrates) on the day of the examination, which could alter loading conditions.

Where it's running

• Philips Healthcare
  Andover, Massachusetts, United States Recruiting

Study contacts

• Study coordinator: Luigi Badano, MD, Ph.D.
• Email: l.badano@auxologico.it
• Phone: +390261911

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.