WithdrawnNot Applicable

Prediction Model of Spontaneous Closure of Congenital Perimembranous Ventricular Septal Defects

Stopped: Repeated application of the same project

China0Started 2020-10-01

Plain-language summary

The objective of this study is to establish a more comprehensive model for evaluating the condition of children with ventricular septal defect and predicting the probability and time of their spontaneous Closure.

Who can participate

Age range

14 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.

Inclusion criteria

. The initial diagnosis age is from birth to 14 years old
. Ultrasonography confirmed the presence of simple PMVSD or other simple congenital heart diseases without other complicated heart malformations (such as pulmonary venous drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.)
. No major disease at first diagnosis (life-threatening organic disease not caused by congenital heart disease)
. The patient or guardian voluntarily signs the informed consent form

Exclusion criteria

. The initial diagnosis age\>14 years old.
. With complicated congenital heart disease (such as pulmonary venous ectopic drainage, conus trunk malformation, interruption of aortic arch, primary pulmonary hypertension, etc.)
. Serious diseases of other organs
. Unable to cooperate with the doctor to complete regular outpatient follow-up or give up treatment

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

Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography

Timeframe: From baseline to December 2022

Trial details

NCT IDNCT07741097

SponsorXinhua Hospital, Shanghai Jiao Tong University School of Medicine

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-12-30

View on ClinicalTrials.gov More Ventricular Septal Defects trials