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

Key facts

Who runs it
Istanbul University - Cerrahpasa
Where
Istanbul, TürkiyeSee the site
Trial code
Status
Recruiting
People taking part
52 people, planned
Started
31 Mar 2026
Expected to end
Apr 2027
Type of study
Observational
Treatments tested
  • Transcatheter Aortic Valve Implantation (TAVI)
Record updated
31 August 2026

Who can take part

Age
18 years and older
Sex
Women and men
Healthy volunteers
Cannot take part

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Interstitial lung disease or pulmonary fibrosis
  • Acute decompensated heart failure
  • Severe exacerbation of chronic obstructive pulmonary disease (COPD)
  • Conditions precluding adequate thoracic ultrasound examination
  • Active pneumonia
  • Massive pleural effusion
  • Severe mitral stenosis
  • Clinically significant severe mitral regurgitation
  • Development of a major complication during the procedure

Where in Türkiye

  • Istanbul University Cerrahpaşa - Cerrahpaşa Faculty of MedicineIstanbul, TürkiyeContact: Metin İlteray Kıkılı, MDTaking people

About the trial

What the trial wants to find out

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.

The group in the trial

  • TAVI Cohort

    Patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Lung ultrasound and echocardiographic assessments will be performed at predefined time points to evaluate changes in pulmonary congestion and aortic valve hemodynamics.

    Treatment: Transcatheter Aortic Valve Implantation (TAVI)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Association Between Changes in Aortic Valve Area and Pulmonary Congestion in Patients Undergoing Transcatheter Aortic Valve Implantation
Record updated
31 August 2026