Heart Failure, DiastolicLVEDPNCT05768698
Assessment of Left Ventricular Filling Pressure by Applying Artificial Intelligence Algorithms to Left Atrial Speckle-tracking Echocardiography
An observational study of Heart Failure, Diastolic and Echocardiography, run by Istituto Auxologico Italiano at 1 site in United States.
Trial summary
The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Diastolic, Echocardiography
- What is being tested?
- Software algorithm
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to 11 Jun 2024
- How long will I take part?
- 1 Month
- 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
- Adult, Older adult
Study population: Consecutive patients referred to our cath lab for clinically indicated coronary angiography or right heart catheterization for the diagnosis of dyspnea
Who may be able to join
- ≥ 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),
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Philips Healthcare
Andover, Massachusetts, 01810
Jane Vogel, 603-489-8329, jane.vogel@philips.com
About this study
Official title: Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco
The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP > 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.
- Conditions
- Heart Failure, Diastolic, Echocardiography
- Being tested
- Software algorithm
- Keywords
- Transthoracic echocardiography, left ventricular filling pressure, artificial intelligence, right heart catheterization
- Medical subject headings
- Heart Failure, Diastolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Software algorithmDiagnostic test
Validation of a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular filling pressure
Invasively measured left ventricular filling pressure by right heart catheterization
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2023
- Study start20 Jul 2021
- Primary completion11 Jun 2024 (estimated)
- Study completion11 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure, DiastolicStudies of the same condition, open and under way.
- More trials run by Istituto Auxologico ItalianoThe sponsor's other registered studies.
- 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
- 20 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Istituto Auxologico Italiano
- Sponsor type
- University, hospital or other
- Collaborators
- Philips Healthcare
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05768698
- Sponsor's protocol ID
- 09V102
- Acronym
- LVEDP
- Status last verified
- Apr 2024
- First submitted
- 22 Feb 2023
- Last updated
- 16 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Available only upon reasonable request to study P.I.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valutazione Delle Pressioni di Riempimento Del Ventricolo Sinistro Attraverso l'Impiego di un Software di Intelligenza Artificiale Applicato Alla Stima Dello Strain Atriale Sinistro Con Ecocardiografia Speckletracking: Studio di Validazione Mediante Cateterismo Cardiaco
- ClinicalTrials.gov ID
- NCT05768698
- Acronym / sponsor ID
- LVEDP / 09V102
- Conditions
- Heart Failure, Diastolic, Echocardiography
- Keywords
- Transthoracic echocardiography, left ventricular filling pressure, artificial intelligence, right heart catheterization
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Auxologico ItalianoUniversity, hospital or other
- Collaborators
- Philips Healthcare
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 11 Jun 2024 (estimated)
- Study completion
- 11 Jun 2024 (estimated)
- First posted
- 14 Mar 2023 (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.
The goal of this single-center, prospective, observational study is to validate a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization; In addition, the added value of this new automated software to detect increased LVEDP > 15 mm Hg compared to the current ASE/EACVI algorithm for assessing diastolic dysfunction and longitudinal left atrial strain during the reservoir phase will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive patients referred to our cath lab for clinically indicated coronary angiography or right heart catheterization for the diagnosis of dyspnea
Key inclusion criteria (4 listed)
- ≥ 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),
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Software algorithmValidation of a software package based on an artificial intelligence algorithm for automated non-invasive estimation of LVFP against invasively measured ones by left and right heart catheterization | Diagnostic test | – |
Primary outcome
Left ventricular filling pressure
Time frame: During procedure
Invasively measured left ventricular filling pressure by right heart catheterization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2024.
- Individual participant dataSharing planned: No. Available only upon reasonable request to study P.I.
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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.
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 Heart Failure, Diastolic and Echocardiography, run by Istituto Auxologico Italiano at 1 site in United States.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 2024. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Luigi Badano, MD, Ph.D. (+390261911 ext. 2319, l.badano@auxologico.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular filling pressure (time frame: During procedure). 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 16 Apr 2024.