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

28 augustus 2026 bijgewerkt door: Metin İlteray Kıkılı, Istanbul University - Cerrahpasa

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Patients with severe symptomatic aortic stenosis scheduled for elective transfemoral TAVI will be prospectively enrolled in this single-center observational cohort study. A total of 52 patients are planned to be included.

Pulmonary congestion will be assessed using standardized lung ultrasound examinations performed at predefined time points during the peri-procedural period. Lung ultrasound assessment will primarily quantify B-lines and will also document relevant findings such as pleural effusion and consolidation. Assessments will be performed before TAVI and repeated after the procedure to characterize temporal changes in pulmonary congestion.

Aortic valve hemodynamics, including aortic valve area, will be assessed by transthoracic echocardiography. The principal analysis will evaluate the relationship between the change in aortic valve area after TAVI and the corresponding change in lung ultrasound findings. In particular, the association between the change in aortic valve area and the change in lung ultrasound findings at 24 hours will be evaluated.

By integrating echocardiographic assessment of valve hemodynamics with serial lung ultrasound, the study aims to characterize the relationship between hemodynamic improvement following TAVI and early changes in pulmonary congestion.

Studietype

Observationeel

Inschrijving (Geschat)

52

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Turkije (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkije (Türkiye), 34098
        • Werving
        • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
        • Contact:

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

The study population will consist of adult patients with severe symptomatic aortic stenosis undergoing elective transfemoral transcatheter aortic valve implantation (TAVI) as part of routine clinical care. Eligible patients will undergo echocardiographic and lung ultrasound assessments at predefined time points to evaluate changes in aortic valve hemodynamics and pulmonary congestion following TAVI.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Interventie / Behandeling
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.
Procedure: Transcatheter Aortic Valve Implantation (TAVI)
Transfemoral transcatheter aortic valve implantation (TAVI) performed as part of routine clinical care in patients with severe symptomatic aortic stenosis. The decision to perform TAVI and procedural management are independent of study participation. No modification of the TAVI procedure is made for research purposes.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
Tijdsspanne: From preprocedural baseline to 24 hours after TAVI
The primary outcome is the correlation between the change in aortic valve area (AVA), measured by transthoracic echocardiography and expressed in cm², and the change in total lung ultrasound (LUS) score after TAVI. Lung ultrasound will be performed at three time points: immediately before anesthesia (T1), immediately after TAVI (T2), and 24 hours after the procedure (T3). Both hemithoraces will be examined in 12 thoracic zones. Each zone will be scored from 0 to 3 according to the degree of loss of aeration: 0 = normal aeration, characterized by A-lines or fewer than 2 B-lines with lung sliding; 1 = mild alveolar-interstitial pattern, characterized by 3 or more well-spaced B-lines with lung sliding; 2 = severe alveolar-interstitial pattern, characterized by multiple crowded and coalescent B-lines occupying >50% of the scanned intercostal space with lung sliding; and 3 = severe loss of aeration, characterized by a tissue-like pattern or consolidation. The scores from all 12 zones will
From preprocedural baseline to 24 hours after TAVI

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Change in B-Line Count After TAVI
Tijdsspanne: From preprocedural baseline to 24 hours after TAVI
Change in the total number of B-lines assessed by lung ultrasound from the preprocedural baseline to 24 hours after transcatheter aortic valve implantation (TAVI). B-lines will be assessed in predefined thoracic zones, and the change in B-line count following TAVI will be evaluated as a marker of change in pulmonary congestion.
From preprocedural baseline to 24 hours after TAVI

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Istanbul University - Cerrahpasa

Onderzoekers

  • Hoofdonderzoeker: Metin İlteray Kıkılı, MD, Istanbul University - Cerrahpasa

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 maart 2026

Primaire voltooiing (Geschat)

1 april 2027

Studie voltooiing (Geschat)

1 april 2027

Studieregistratiedata

Eerst ingediend

25 augustus 2026

Eerst ingediend dat voldeed aan de QC-criteria

28 augustus 2026

Eerst geplaatst (Werkelijk)

31 augustus 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 augustus 2026

Laatste update ingediend die voldeed aan QC-criteria

28 augustus 2026

Laatst geverifieerd

1 augustus 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • Ay099DWe

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

NEE

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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