UnknownNot Applicable

Outcome of Balloon Pulmonary Valvuloplasty in Patients With Congenital Pulmonary Stenosis in Terms of Reverse Right Ventricular Remodelling and Functional Exercise Capacity

Egypt30 participantsStarted 2021-01-10

Plain-language summary

A prospective of 30 patients with symptomatic severe congenital valvular pulmonary stenosis who are indicated for percutaneous balloon pulmonary valvuloplasty . the aim is to 1. \- evaluate electrical and mechanical remodeling of RV 6 months following balloon dilation 2. \- evaluate Functional capacity using 6MWT and SaO2 before and 6 months following BPV

Who can participate

Age range

16 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

. Patients with isolated supra-valvular and sub valvular pulmonary stenosis
. Patients with peripheral pulmonary stenosis.
. Patients with pulmonary stenosis if part of another congenital heart disease .
. Patients with organically diseased Tricuspid valve
. Patients with any significant shunt lesion which result in dilation in RV such as atrial septal defect.
. Patients with right ventricular dysfunction due to arrhythmogenic right ventricular dysplasia (ARVD) or non compaction

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

reverse Right ventricular remodeling

Timeframe: one year

functional exercise capacity

Timeframe: one year

Trial details

NCT IDNCT05828524

SponsorAssiut University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2024-12

View on ClinicalTrials.gov More Congenital Heart Disease trials