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The FUnctional TricUspid REgurgitation by 3D EChocardiography Cooperative Study

Recruitingn/aAges 18 Years - anyAllIstituto Auxologico Italiano
NCT05747404 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

Prospective, multicenter, observational study to enroll consecutive patients with functional tricuspid regurgitation (FTR) with the primary aim to: * Use patients' outcomes as a reference to try to define the threshold values for the different grades of FTR severity; and secondary aims to: * Use 3D echocardiography to assess the relationships among the geometry (size and shape) of the right ventricle, right atrium, tricuspid annulus, and tricuspid leaflets according to the underlying cardiac condition (i.e., atrial fibrillation, pulmonary hypertension, right ventricular cardiomyopathy, congenital heart diseases, etc.) * Assess the accuracy, and incremental diagnostic and prognostic value of a new software package to measure tricuspid annulus and valve geometry * Develop new parameters of FTR severity that take into account the lower momentum of the tricuspid regurgitant jet (compared wi

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📋 Eligibility rules (as published)
Inclusion Criteria: * older than 18 years, * signed informed consent to be part of this study, * no pregnancy, * the presence of at least one of the following cardiac conditions: a. Permanent atrial fibrillation b. Pulmonary arterial hypertension c. Left heart diseases with increased postcapillary pressure d. Right ventricular cardiomyopathy e. Right ventricular infarction f. Chronic thromboembolic pulmonary embolism g. Congenital diseases with right ventricular volume overload (atrial septal defect, interventricular septal defect, pulmonary regurgitation) h. Previous left heart valve surgery I. Good enough acoustic window and patient cooperation to obtain 3D echo data sets of the right ventricle, right atrium and tricuspid valve with a minimum temporal resolution of 20 vps l. Availability for clinical and echocardiography follow-up Exclusion Criteria: * Unwillingness to be part of the study * Primary tricuspid valve disease * Patient already scheduled for tricuspid valve repair/replacement * Cardiac pacemaker, ICD or CRT leads * Poor acoustic window * Impossibility of left lateral decubitus position * Extreme heart rates (\<50 or \>100 bpm) * Previous LVAD implantation
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What it tests

  • Echocardiography
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Where

4 sites
Istituto Auxologico Italiano, IRCCS
Milan, Italy
University of Padova
Padova, Italy
University of Medicine and Pharmacy Carol Davila
Bucharest, Romania
University of Medicine and Pharmacy of Craiova
Craiova, Romania
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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