Skip to content

Research on precise and individualized postoperative optimization and improvement of functional single ventricle surgery and preoperative virtual design

A random, controlled, prospective study of CFD technology assisted functional single-ventricular TCPC operation design

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000035675
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

intervention group:Preoperative CFD modeling

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) Underwent two-way total vena cava pulmonary anastomosis, Glenn surgery at Shanghai Children's Medical Center and multi-center research center; 2) More than 12 months before Glenn surgery; 3) Children with Glenn surgery on the right side; 4) younger than 18 years old; 5) NYHA grade I-II; 6) Meet the definition of functional single ventricle anatomy; 7) Obtain written consent from guardian.

Exclusion criteria

Exclusion criteria: 1) mPAP before surgery greater than 18mmHg; 2) Nakata Index <80 before operation; 3) Unable to perform MRI\cardiac catheterization or contrast agent allergy before surgery; 4) During the operation, it was found that it was impossible to realize the computer simulation operation plan; 5) In addition to the establishment of the Fontan cycle during the operation, the accompanying operations are performed; 6) Echocardiogram reveals known Glenn anastomotic obstruction, pulmonary artery stenosis, or pulmonary vein stenosis (pressure difference greater than 4mmHg); 7) MRI suggests single lung physiology: more than 80% of blood flow to one lung.

Design outcomes

Primary

MeasureTime frame
iPL;

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