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Research on the clinical techniques and strategies for biventricular conversion for functional single ventricles based on individualized anatomical characteristics and preoperative precise guidance

A prospective study of CFD assisted biventricular conversion for functional single ventricles

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035701
Enrollment
Unknown
Registered
2020-08-16
Start date
2020-10-01
Completion date
Unknown
Last updated
2020-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

functional single ventricle

Interventions

Case series:biventricular conversion

Sponsors

Heart Center, Shanghai Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 18 Years

Inclusion criteria

Inclusion criteria: 1. In consistence with the definition of functional single ventricle; 2. Underwent total caval-pulmonary connection, namely Fontan operation; or underwent bidirectional caval-pulmonary connection, namely Glenn operation but not completed the Fontan operation, at Shanghai Children's Medical Center; 3. Poor outcomes indicated by hemodynamics parameters; or having shown the clinical symptoms of Fontan-cycle failure (NYHA III-IV, pulmonary arteriovenous fistulas; protein-losing enteropathy; refractory arrhythmia, etc.); 4. Younger than 18 years old; 5. Obtain written informed consent by guradians.

Exclusion criteria

Exclusion criteria: 1. Unable to perform CT/MRI/cardiac catheterization or contrast agent allergy before surgery; 2. Inappropriate for biventricular conversion during preoperative evaluation; 3. During the operation, it was found that it was impossible to realize the biventricular conversion.

Design outcomes

Primary

MeasureTime frame
quality of life;

Countries

China

Contacts

Public ContactHaibo Zhang

Shanghai Children's Medical Center

zhanghaibo@scmc.com.cn+86 18930830772

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026