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

28. august 2026 oppdatert av: 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.

Studieoversikt

Status

Rekruttering

Forhold

Intervensjon / Behandling

Detaljert beskrivelse

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

Observasjonsmessig

Registrering (Antatt)

52

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Tyrkia (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Tyrkia (Türkiye), 34098
        • Rekruttering
        • Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
        • Ta kontakt med:

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

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.

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Intervensjon / Behandling
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.
Fremgangsmåte: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Change in B-Line Count After TAVI
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Istanbul University - Cerrahpasa

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

31. mars 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. april 2027

Datoer for studieregistrering

Først innsendt

25. august 2026

Først innsendt som oppfylte QC-kriteriene

28. august 2026

Først lagt ut (Faktiske)

31. august 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. august 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. august 2026

Sist bekreftet

1. august 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • Ay099DWe

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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