Association Between Changes in Aortic Valve Area and Pulmonary Congestion After Transcatheter Aortic Valve Implantation
28 augusti 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Observationell
Inskrivning (Beräknad)
52
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Metin İlteray Kıkılı, MD
- Telefonnummer: +905439782131
- E-post: metin.kikili@iuc.edu.tr
Studieorter
-
-
Istanbul
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Istanbul, Istanbul, Turkiet (Türkiye), 34098
- Rekrytering
- Istanbul University-Cerrahpaşa, Cerrahpaşa Faculty of Medicine
-
Kontakt:
- Metin İlteray Kıkılı, MD
- Telefonnummer: +905439782131
- E-post: metin.kikili@iuc.edu.tr
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Testmetod
Icke-sannolikhetsprov
Studera befolkning
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.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / 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.
|
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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score After TAVI
Tidsram: 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
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From preprocedural baseline to 24 hours after TAVI
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Change in B-Line Count After TAVI
Tidsram: 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
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Metin İlteray Kıkılı, MD, Istanbul University - Cerrahpasa
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
31 mars 2026
Primärt slutförande (Beräknad)
1 april 2027
Avslutad studie (Beräknad)
1 april 2027
Studieregistreringsdatum
Först inskickad
25 augusti 2026
Först inskickad som uppfyllde QC-kriterierna
28 augusti 2026
Första postat (Faktisk)
31 augusti 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
31 augusti 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 augusti 2026
Senast verifierad
1 augusti 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
- Aortaklaffssjukdom
- Hjärt-kärlsjukdomar
- Hjärtsjukdom
- Hjärtklaffssjukdomar
- Ventrikulärt utflödeshinder
- Aortaklaffstenos
- Kirurgiska ingrepp, operativ
- Hjärtkirurgiska ingrepp
- Hjärtkirurgiska ingrepp
- Thoraxkirurgiska ingrepp
- Protesimplantation
- Hjärtventilprotesimplantation
- Transkateter aortaventilersättning
Andra studie-ID-nummer
- Ay099DWe
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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