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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstanbul University - Cerrahpasa

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Diagnosis of severe symptomatic aortic stenosis

Scheduled for elective transfemoral transcatheter aortic valve implantation (TAVI)

Availability of preprocedural transthoracic echocardiography

Disqualifiers

Active pneumonia

Interstitial lung disease or pulmonary fibrosis

Massive pleural effusion

Acute decompensated heart failure

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Transcatheter Aortic Valve Implantation (TAVI)

    Procedure/Surgery

    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.

Treatment groups

52 Participants
are divided into 1 treatment group
Group A: TAVI Cohort1 intervention

Trial outcomes

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

Time frame
From preprocedural baseline to 24 hours after TAVI

Secondary outcomes

1

Change in B-Line Count 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.

Time frame
From preprocedural baseline to 24 hours after TAVI

Other outcomes

Sponsors and contacts

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