NCT07794436 Association Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation
| NCT ID | NCT07794436 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istanbul University - Cerrahpasa |
| Condition | Aortic Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 52 participants |
| Start Date | 2026-03-31 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 52 participants in total. It began in 2026-03-31 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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
Contact & Investigator
Metin İlteray Kıkılı, MD
PRINCIPAL INVESTIGATOR
Istanbul University - Cerrahpasa
Frequently Asked Questions
Who can join the NCT07794436 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Aortic Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07794436 currently recruiting?
Yes, NCT07794436 is actively recruiting participants. Contact the research team at metin.kikili@iuc.edu.tr for enrollment information.
Where is the NCT07794436 trial being conducted?
This trial is being conducted at Istanbul, Turkey (Türkiye).
Who is sponsoring the NCT07794436 clinical trial?
NCT07794436 is sponsored by Istanbul University - Cerrahpasa. The principal investigator is Metin İlteray Kıkılı, MD at Istanbul University - Cerrahpasa. The trial plans to enroll 52 participants.