Prediction Model of Spontaneous Closure of Congenital Perimembranous Ventricular Septal Defects

NCT07741097 | Withdrawn DMC

• 1 other identifier: XH-20-021
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ventricular Septal Defects

Keywords

Prediction Model; Data Mining; Spontaneous Closure; Congenital Heart Disease; Perimembranous Ventricular Septal Defects

Outcome Measures

Primary Outcomes (1)

• 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.

  From baseline to December 2022

Study Arms (2)

PMVSD spontaneously closed group

Echocardiography diagnosis of PMVSD spontaneous closure

PMVSD unclosed group

Including defect reduction group and surgery group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Probability Sample

Study Population

PMVSD children aged 0 to 14

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Heart Septal Defects, Ventricular; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Heart Septal Defects; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Pengjun Zhao, MD

  Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor of Department of Pediatric Cardiology

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: August 3, 2026
• Study Start: October 1, 2020
• Primary Completion: December 30, 2021
• Study Completion: December 30, 2022
• Last Updated: August 3, 2026

Record last verified: 2020-08

Locations

CN (1)