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Clinical Trial NCT07363538 for Complex Congenital Heart Disease is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here.
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Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease 738 Randomized Multi-Center

Recruiting
Clinical Trial NCT07363538 is an interventional study for Complex Congenital Heart Disease that is recruiting. It started on December 1, 2025 with plans to enroll 738 participants. Led by Central China Fuwai Hospital of Zhengzhou University, it is expected to complete by January 31, 2029. The latest data from ClinicalTrials.gov was last updated on January 23, 2026.
Brief Summary
There remains controversy regarding the optimal timing of surgical treatment for neonatal CCHD (Complex Congenital Heart Disease). Based on the established national multi-center database for surgical treatment of congenital heart disease and the prenatal-postnatal integrated diagnosis and treatment model, this study will conduct a multi-center RCT (Randomized Controlled Trial) to explore the optimal surgical timing f...Show More
Official Title

Multicenter Randomized Controlled Trial (RCT) and Efficacy Evaluation System Study on Surgical Innovation Strategies for Neonatal Complex Congenital Heart Disease

Conditions
Complex Congenital Heart Disease
Other Study IDs
  • 2024ZD0527003
NCT ID Number
NCT07363538
Start Date (Actual)
2025-12-01
Last Update Posted
2026-01-23
Completion Date (Estimated)
2029-01-31
Enrollment (Estimated)
738
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
OtherControl Group
Surgical operation is performed on neonates aged \>7 days (postnatal age)
Surgical operation is performed on neonates aged >7 days (postnatal age)
Surgical operation is performed on neonates aged \>7 days (postnatal age)
ExperimentalExperimental Group
Surgical operation is performed on neonates aged \< 7 days (postnatal age)
Surgical operation is performed on neonates aged < 7 days (postnatal age).
Surgical operation is performed on neonates aged \< 7 days (postnatal age).
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Perioperative Mortality and Non-Rehabilitation Discharge Rate
From enrollment to 1 year after surgery
Participation Assistant
Eligibility Criteria

Eligible Ages
Child
Eligible Sexes
All
  1. Neonates diagnosed with TAPVC, CoA/IAA, TGA, PA/IVS, or severe PS via pre-admission cardiac echocardiography;
  2. Patients and families demonstrating high compliance, willing to sign informed consent forms and agree to complete one year of follow-up and related examinations.

  1. Preterm infant (gestational age < 36 weeks at birth);
  2. Low birth weight (weight < 2.5 kg);
  3. Concurrent severe extracardiac anomalies or complex cardiac malformations;
  4. Preoperative respiratory or circulatory instability requiring emergency surgery.
Central China Fuwai Hospital of Zhengzhou University logoCentral China Fuwai Hospital of Zhengzhou University
Study Responsible Party
Qihang Yang, Principal Investigator, postgraduate student, Central China Fuwai Hospital of Zhengzhou University
Study Central Contact
Contact: Song Shubo Shubo Song, 13523535453, [email protected]
12 Study Locations in 1 Countries

Beijing Municipality

Fuwai Hospital, Chinese Academy of Medical Sciences, Beijing, Beijing Municipality, 100037, China
Recruiting

Chongqing Municipality

Children's Hospital of Chongqing Medical University, Chongqing, Chongqing Municipality, China
Not yet recruiting

Guangdong

Guangzhou Women and Children's Medical Center, Guangzhou Medical University, Guangzhou, Guangdong, China
Not yet recruiting

Henan

Central China Fuwai Hospital of Zhengzhou University, Zhengzhou, Henan, 450000, China
Recruiting

Hubei

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, Hubei, China
Not yet recruiting

Hunan

The Second Xiangya Hospital of Central South University, Changsha, Hunan, China
Not yet recruiting

Jiangsu

Children's Hospital Affiliated to Nanjing Medical University, Nanjing, Jiangsu, 210008, China
Not yet recruiting

Shandong

Qingdao Women and Children's Hospital, Qingdao, Shandong, 266000, China
Not yet recruiting

Shanghai Municipality

Shanghai Children's Medical Center (SCMC) Affiliated to Shanghai Jiao Tong University School of Medicine, Shanghai, Shanghai Municipality, China
Not yet recruiting

Shanxi

The First Affiliated Hospital of Air Force Medical University (Xijing Hospital), Xi’an, Shanxi, China
Not yet recruiting

Sichuan

West China Second Hospital of Sichuan University, Chengdu, Sichuan, China
Not yet recruiting

Zhejiang

Children's Hospital Zhejiang University School of Medicine, Hangzhou, Zhejiang, China
Not yet recruiting