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

NCT07794436 | Recruiting

• 1 other identifier: Ay099DWe
• Study Type: observational
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Stenosis

Keywords

Transcatheter Aortic Valve Implantation; TAVI; Lung Ultrasound; B-lines; Pulmonary Congestion; Aortic Valve Area; Aortic Stenosis; Lung Ultrasound Score

Outcome Measures

Primary Outcomes (1)

• Correlation Between Change in Aortic Valve Area and Change in Total Lung Ultrasound Score 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

Secondary Outcomes (1)

• Change in B-Line Count After TAVI

  From preprocedural baseline to 24 hours after TAVI

Study Arms (1)

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)

Interventions

Transcatheter Aortic Valve Implantation (TAVI) PROCEDURE

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.

TAVI Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul University - Cerrahpasa: lead

Study Sites (1)

Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

Istanbul, Istanbul, 34098, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Aortic Valve Stenosis

Interventions

Transcatheter Aortic Valve Replacement

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction

Intervention Hierarchy (Ancestors)

Heart Valve Prosthesis Implantation; Cardiac Surgical Procedures; Cardiovascular Surgical Procedures; Surgical Procedures, Operative; Prosthesis Implantation; Thoracic Surgical Procedures

Study Officials

• Metin İlteray Kıkılı, MD

  Istanbul University - Cerrahpasa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Metin İlteray Kıkılı, MD

CONTACT

+905439782131; metin.kikili@iuc.edu.tr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiologist

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 31, 2026
• Study Start: March 31, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: August 31, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)