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Does replacing a heart valve clear fluid from the lungs?

NCT ID NCT07794436

Knowledge-focused Sponsor: Istanbul University - Cerrahpasa Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 31, 2026 · Last updated Sep 01, 2026 · Updated 1 time

Summary

This study looks at people with severe aortic stenosis, a narrowing of the heart's main valve, who are scheduled for a procedure called TAVI to replace that valve. Researchers want to see if improving blood flow through the valve also reduces fluid buildup in the lungs, a sign of heart failure. They will use lung ultrasound to measure fluid before, right after, and 24 hours after the procedure, and compare those readings with changes in the valve opening size. The goal is to understand how valve repair affects lung congestion.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Transcatheter aortic valve implantation (TAVI), a procedure to replace the aortic valve without open-heart surgery
What this could lead to
If it works, this could help doctors predict which patients benefit most from TAVI and guide follow-up care.
What could go wrong
This is a small observational study, so it cannot prove cause and effect. Results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 52 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

aortic valve stenosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Aortic stenosis

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine

    RECRUITING

    Istanbul, Istanbul, 34098, Turkey (Türkiye)

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