Ventricular Septal DefectsNCT07741097
Prediction Model of Spontaneous Closure of Congenital Perimembranous Ventricular Septal Defects
An observational study of Ventricular Septal Defects, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 14 years
- Conditions the study is for
- Ventricular Septal Defects
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2020to 30 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 14 years
- All sexes
- No healthy volunteers
- Child
Study population: PMVSD children aged 0 to 14
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: Study on the Predicting Model for Spontaneous Closure of Perimembranous Ventricular Septal Defects in Children- An Observational Research Based on the Real World
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.
Read the detailed description
This is an observational study with sufficient and complete preliminary research and pre-experimental foundations. This study used the "National Congenital Heart Disease Collaboration Network" platform to retrospectively collect electronic medical record of children with Perimembranous Ventricular Septal Defect（PMVSD）that met the criteria of this study. The minimum sample size is estimated to be 4,500. According to the observation of the natural course of PMVSD in children, they were divided into PMVSD spontaneously closed group and unclosed group. The objective of this study is to establish a data model, which can predict the spontaneous closure probability of congenital perimembranous ventricular septal defect and provide reliable basis for clinical diagnosis and therapy. Through the experience screening of clinical experts and big clinical data mining of large samples, PMVSD spontaneous closure related variables were extracted and were used to establish a more accurate and objective prediction for the natural course of PMVSD.This could provide reliable information for the clinical surgery timing and indications urgery thus is of important social significance and economic value.
- Conditions
- Ventricular Septal Defects
- Keywords
- Prediction Model, Data Mining, Spontaneous Closure, Congenital Heart Disease, Perimembranous Ventricular Septal Defects
- Medical subject headings
- Heart Septal Defects, Ventricular, Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| PMVSD spontaneously closed group | Echocardiography diagnosis of PMVSD spontaneous closure | |
| PMVSD unclosed group | Including defect reduction group and surgery group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography
Spontaneous closure is defined as the absence of a ventricular septal defect shunt on color Doppler echocardiography, without prior surgical or transcatheter closure intervention.
Measured: From baseline to December 2022
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Oct 2020 (estimated)
- Primary completion30 Dec 2021 (estimated)
- Study completion30 Dec 2022 (estimated)
Why it stopped: Repeated application of the same project
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventricular Septal DefectsStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jing Sun, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Pengjun Zhao, MD, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07741097
- Sponsor's protocol ID
- XH-20-021
- Status last verified
- Aug 2020
- First submitted
- 26 Aug 2020
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Predicting Model for Spontaneous Closure of Perimembranous Ventricular Septal Defects in Children- An Observational Research Based on the Real World
- ClinicalTrials.gov ID
- NCT07741097
- Acronym / sponsor ID
- XH-20-021
- Conditions
- Ventricular Septal Defects
- Keywords
- Prediction Model, Data Mining, Spontaneous Closure, Congenital Heart Disease, Perimembranous Ventricular Septal Defects
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Repeated application of the same project
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 1 Oct 2020 (estimated)
- Primary completion
- 30 Dec 2021 (estimated)
- Study completion
- 30 Dec 2022 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is an observational study with sufficient and complete preliminary research and pre-experimental foundations. This study used the "National Congenital Heart Disease Collaboration Network" platform to retrospectively collect electronic medical record of children with Perimembranous Ventricular Septal Defect（PMVSD）that met the criteria of this study. The minimum sample size is estimated to be 4,500. According to the observation of the natural course of PMVSD in children, they were divided into PMVSD spontaneously closed group and unclosed group. The objective of this study is to establish a data model, which can predict the spontaneous closure probability of congenital perimembranous ventricular septal defect and provide reliable basis for clinical diagnosis and therapy. Through the experience screening of clinical experts and big clinical data mining of large samples, PMVSD spontaneous closure related variables were extracted and were used to establish a more accurate and objective prediction for the natural course of PMVSD.This could provide reliable information for the clinical surgery timing and indications urgery thus is of important social significance and economic value.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PMVSD spontaneously closed group | – | –Echocardiography diagnosis of PMVSD spontaneous closure |
| PMVSD unclosed group | – | –Including defect reduction group and surgery group |
Who may qualify
- Ages
- Up to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- PMVSD children aged 0 to 14
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography
Time frame: From baseline to December 2022
Spontaneous closure is defined as the absence of a ventricular septal defect shunt on color Doppler echocardiography, without prior surgical or transcatheter closure intervention.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pengjun Zhao, MD principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ventricular Septal Defects, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with spontaneous closure of perimembranous ventricular septal defect confirmed by echocardiography (time frame: From baseline to December 2022). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.