Association Between Aortic Valve Area Changes and Pulmonary Congestion After TAVI
Official title: Association Between Changes in Aortic Valve Area and Pulmonary Congestion in Patients Undergoing Transcatheter Aortic Valve Implantation
Run by Istanbul University - Cerrahpasa · NCT07794436 · Data updated 2026-11-12
This study tests whether improvements in aortic valve opening after TAVI relate to reductions in lung congestion measured by ultrasound in adults with severe aortic stenosis.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 52 (estimated) |
| Sponsor | Istanbul University - Cerrahpasa Academic / other |
| Locations | 1 site (Istanbul, Istanbul) |
| Status | Recruiting |
| Started | March 31, 2026 |
| Main results expected | April 2027 |
| Study ends | April 2027 |
| Registry record updated | August 31, 2026 |
| Trial ID | NCT07794436 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults with severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI who can undergo preprocedural echocardiography and thoracic lung ultrasound.
✕Probably not a fit
Patients with active pneumonia, interstitial lung disease, large pleural effusions, or other conditions limiting ultrasound accuracy may not experience benefit from the study findings.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a prospective, single-center observational study enrolling adults with severe symptomatic aortic stenosis undergoing elective transfemoral TAVI. It uses lung ultrasound to quantify pulmonary congestion, focusing on B-lines, before and after the procedure, and correlates these findings with changes in aortic valve area measured by echocardiography. The primary goal is to see if an increase in valve area after TAVI is associated with improvement in lung ultrasound signs of congestion, particularly at 24 hours post-procedure. The study plans to enroll 52 participants and will include predefined time points for peri-procedural assessments.
Why it matters
Potential benefit: If successful, the study could help clinicians anticipate short-term improvements in pulmonary congestion after TAVI based on valve-area changes.
How similar studies have gone: Previous research in related areas suggests a link between hemodynamic relief after valve interventions and changes in pulmonary imaging, though this exact association with TAVI and lung ultrasound findings is not yet established.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
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Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine
Istanbul, Istanbul, Turkey (Türkiye) Recruiting
Study contacts
- Principal investigator: Metin İlteray Kıkılı, MD — Istanbul University - Cerrahpasa
- Study coordinator: Metin İlteray Kıkılı, MD
- Email: metin.kikili@iuc.edu.tr
- Phone: +905439782131
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.