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A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma

N

National Center for Cardiovascular Diseases

Status

Completed

Conditions

Cardiac Tumor

Treatments

Procedure: ventricular reconstruction

Study type

Observational

Funder types

Other

Identifiers

NCT07132593
T2024-ZX007-1

Details and patient eligibility

About

This study was a retrospective descriptive case series analyzing outcomes of a novel surgical approach This study aimed to evaluate a modified surgical technique-called the Sandwich Procedure-for reconstructing the heart after resection of cardiac fibromas in children. Cardiac fibroma is a rare benign tumor that can compress vital cardiac structures and cause serious symptoms such as arrhythmia, heart failure, or obstruction of blood flow. Surgical removal is often required, but large tumors may leave defects in the heart wall that are challenging to repair, especially in young children.

The Sandwich Procedure was developed at our institution to improve the strength and stability of heart wall reconstruction after tumor removal. It involves suturing two layers of treated biological tissue-both inside and outside the heart wall-to restore normal shape and function, while minimizing the risk of complications like aneurysm or bleeding. This retrospective, observational study includes pediatric patients who underwent this procedure between 2018 and 2023. We report on its surgical feasibility, short- and mid-term outcomes, and potential benefits in preserving cardiac function.

Enrollment

17 patients

Sex

All

Ages

Under 14 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • underwent cardiac tumor resection
  • underwent ventricular reconstruction with the Sandwich Procedure

Exclusion criteria

  • the final pathological diagnosis indicated other than cardiac fibroma
  • the final pathological diagnosis indicated metastatic tumors
  • incomplete clinical or follow-up data

Trial design

17 participants in 1 patient group

Surgical group
Description:
Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure.
Treatment:
Procedure: ventricular reconstruction

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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