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Heart valve procedure: who might face problems later?

NCT ID NCT07191093

Knowledge-focused Sponsor: Assiut University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026

Summary

This study follows 50 people who had a minimally invasive procedure to widen a narrowed heart valve (pulmonary balloon valvuloplasty). The goal is to see how often the right side of the heart struggles afterward and what factors might predict that. Researchers will track changes in heart function over time using ultrasound and other measures.

What this could mean

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

Active substance
pulmonary balloon valvuloplasty (a catheter procedure to widen a narrowed heart valve)
What this could lead to
If successful, this could help doctors identify patients at higher risk for heart dysfunction after the procedure, potentially improving follow-up care.
What could go wrong
This is a small, observational study with only 50 participants, so results may not apply to everyone. It does not test a new treatment, only looks for patterns.

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 50 people

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

Started

Aug 2025

Expected to finish

Oct 2026

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 will include patients with isolated valvular pulmonary stenosis undergoing pulmonary balloon valvuloplasty (PBV) at the Cardiovascular Department, Assiut University Hospitals over 3 years. All ages will be included. Exclusion criteria: patients with subvalvular/supravalvular PS, other major congenital heart disease, previous valve intervention, hemodynamic shock, or poor echo windows. A minimum of 60 patients will be recruited. Clinical data, ECG, echo (including speckle tracking), and procedural details will be collected. Patients will be followed at discharge, 1 month, and 6 months to assess RV function and outcomes.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: * Any age group(no age restriction) Diagnosis of isolated valvular pulmonary stenosis confirmed by echocardiographic evaluation. Patients who have undergone or are scheduled to undergo successful pulmonary balloon valvuloplasty (PBV), defined as a post-procedural peak gradient \<40 mmHg with no significant residual obstruction. Normal or mildly dysplastic pulmonary valve morphology suitable for balloon valvuloplasty. No history of prior cardiac surgery or transcatheter pulmonary valve intervention. Exclusion Criteria: * Presence of other congenital heart diseases (e.g., TOF, VSD, ASD) Previous surgical or catheter-based intervention on the pulmonary valve. Dysplastic pulmonary valve morphology not suitable for PBV Subvalvular or supravalvular pulmonary stenosis. Development of significant procedural complications, such as severe pulmonary regurgitation requiring urgent surgical intervention. Patients in hemodynamic shock, with uncontrolled arrhythmias, or other unstable clinical conditions that may interfere with echocardiographic evaluation or follow-up. Presence of major systemic illnesses (e.g., advanced hepatic, renal, or pulmonary disease) that could independently affect right heart function or limit follow-up.

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Conditions

The condition(s) this trial relates to.

congenital pulmonary valve stenosis pulmonary valve stenosis

As listed by the trial registrant

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

Pulmonary valvuloplasty RV dysfunction

Contacts and locations

Locations

  • Assiut University

    Asyut, Egypt

More trials for these conditions

Other studies related to the condition(s) this trial covers.