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Association Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation

Recruitingn/aAges 18 Years - anyAllIstanbul University - Cerrahpasa
NCT07794436 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

This prospective, single-center observational study aims to evaluate the relationship between changes in aortic valve hemodynamics and pulmonary congestion in patients undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) for severe symptomatic aortic stenosis. Pulmonary congestion will be assessed non-invasively using lung ultrasound, with particular emphasis on B-lines, at predefined time points before and after TAVI. Changes in aortic valve area and other echocardiographic parameters will be evaluated in relation to changes in lung ultrasound findings. The primary objective is to determine the association between improvement in aortic valve area following TAVI and changes in pulmonary congestion.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Age ≥18 years * Diagnosis of severe symptomatic aortic stenosis * Scheduled for elective transfemoral transcatheter aortic valve implantation (TAVI) * Availability of preprocedural transthoracic echocardiography * Feasibility of lung ultrasound examination * Provision of written informed consent Exclusion Criteria: * Active pneumonia * Interstitial lung disease or pulmonary fibrosis * Massive pleural effusion * Acute decompensated heart failure * Severe exacerbation of chronic obstructive pulmonary disease (COPD) * Conditions precluding adequate thoracic ultrasound examination * Severe mitral stenosis * Clinically significant severe mitral regurgitation * Development of a major complication during the procedure
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What it tests

  • Transcatheter Aortic Valve Implantation (TAVI)
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Where

1 site
Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Turkey (Türkiye)
🤝 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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