Predictors of RV Dysfunction After BPV (NCT07191093) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predictors of RV Dysfunction After BPV
Egypt50 participantsStarted 2025-08-01
Plain-language summary
This aim focuses on :
Assessing how common RV dysfunction is post-procedure Evaluating RV function changes over time (e.g., TAPSE, FAC, RV strain if available) Identifying risk factors or predictors (e.g., high residual gradient, severe PR, age at intervention)
Who can participate
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.
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.
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
1
Change in peak transvalvular gradient after PBV
Timeframe: Baseline, 72 hours post-procedure, and 6 months follow-up.
2
Change in mean transvalvular gradient after pulmonary balloon valvuloplasty
Timeframe: Baseline, 72 hours post-procedure, and 6 months follow-up.
3
Change in estimated pulmonary artery systolic pressure PASP after PBV
Timeframe: Baseline, 72 hours post-procedure, and 6 months follow-up.
4
Change in TAPSE after PBV
Timeframe: Baseline, 72 hours post-procedure, and 12 months follow-up