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Study on the individualized multidisciplinary comprehensive diagnosis and treatment of the biventricular conversion in functional single ventricle patients

Non-inferiority, prospective, non-randomized, controlled clinical trial of biventricular conversion compared with traditional Fontan surgery

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000036700
Enrollment
Unknown
Registered
2020-08-24
Start date
2020-09-01
Completion date
Unknown
Last updated
2020-09-21

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:Biventricular conversion surgery
Control Group:Fontan surgery

Sponsors

Heart Center, Shanghai Children's Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1) Children with functional single ventricle treated at Shanghai Children's Medical Center; 2) The age is greater than 4 years old and younger than 18 years old; 3) NYHA grade I-II; 4) Meet the definition of functional single ventricle anatomy; 5) Obtain written consent from guardian.

Exclusion criteria

Exclusion criteria: 1) Anatomy of single ventricle, tricuspid atresia, right ventricle dependent coronary circulation; 2) Unable to perform cardiac catheterization or contrast agent allergy before surgery; 3) CPET examination cannot be performed before surgery; 4) mPAP before surgery is greater than 18mmHg; 5) Nakata Index 160mmHg, diastolic blood pressure> 100mmHg; 10) Severe arrhythmia before surgery; 11) Hypotension: systolic blood pressure 120 BPM; 13) General exclusions: psychiatric and/or social barriers, patients with a history of severe allergies or multiple drug allergies, other known organ insufficiency.

Design outcomes

Primary

MeasureTime frame
% Predicted peak VO2;—

Countries

China

Contacts

Public ContactHaibo Zhang
zhanghaibo@scmc.com.cn+86 18930830772

Outcome results

None listed

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