The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT05768698
Recruitment Status : **RECRUITING NOW**
First Posted : March 14, 2023
Last Update Posted : March 14, 2023
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Istituto Auxologico Italiano
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Brief 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 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.
Heart Failure, Diastolic Echocardiography
Diagnostic Test: Software algorithm
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Study Type :
Observational [Patient Registry]
Estimated Enrollment :
20 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Target Follow-Up Duration:
1 Month
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
Actual Study Start Date :
July 20, 2021
Estimated Primary Completion Date :
June 11, 2023
Estimated Study Completion Date :
June 11, 2023
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Intervention Details:
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Primary Outcome Measures :
Left ventricular filling pressure [ Time Frame: During procedure ]
Invasively measured left ventricular filling pressure by right heart catheterization
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Information from the National Library of Medicine
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Ages Eligible for Study: Â
18 Years and older  (Adult, Older Adult)
Sexes Eligible for Study: Â
All
Sampling Method: Â
Non-Probability Sample
Consecutive patients referred to our cath lab for clinically indicated coronary angiography or right heart catheterization for the diagnosis of dyspnea
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.
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Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05768698
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Philips Healthcare
Andover, Massachusetts, United States, 01810
Contact: Jane Vogel   603-489-8329   jane.vogel@philips.com  Â
Istituto Auxologico Italiano
Philips Healthcare
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Responsible Party:
Istituto Auxologico Italiano
ClinicalTrials.gov Identifier:
NCT05768698 Â Â
Other Study ID Numbers:
09V102
First Posted:
March 14, 2023 Â Â Key Record Dates
Last Update Posted:
March 14, 2023
Last Verified:
February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
No
Plan Description:
Available only upon reasonable request to study P.I.
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Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Istituto Auxologico Italiano:
Transthoracic echocardiographyleft ventricular filling pressureartificial intelligenceright heart catheterization
Additional relevant MeSH terms:
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Heart Failure, DiastolicHeart FailureHeart DiseasesCardiovascular Diseases
Source: View full study details on ClinicalTrials.gov
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. By listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
