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

NCT07132593 | Completed

• 1 other identifier: T2024-ZX007-1
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cardiac Tumor

Keywords

congenital heart disease; cardiac tumor; surgical technique

Outcome Measures

Primary Outcomes (1)

• composite endpoint

  all-cause mortality or cardiac reoperation

  up to 5 years

Secondary Outcomes (5)

• ventricular failure

  up to 5 years

• ventricular aneurysm

  up to 5 years

• malignant arrhythmia

  up to 5 years

• Heart block

  up to 5 years

• severe perioperative complications

  before discharge

Study Arms (1)

Surgical group

Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure.

Procedure: ventricular reconstruction

Interventions

ventricular reconstruction PROCEDURE

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.

Surgical group

Eligibility Criteria

• Age: Up to 14 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

patients underwent cardiac fibroma resection followed by ventricular reconstruction with the Sandwich Procedure at our institution

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• China National Center for Cardiovascular Diseases: lead

Study Sites (1)

Pediatric Cardiac Surgery Center, Fuwai Hospital

Beijing, Beijing Municipality, 100037, China

Location

MeSH Terms

Conditions

Heart Neoplasms; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Heart Diseases; Cardiovascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2025
• First Posted: August 20, 2025
• Study Start: January 1, 2018
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2025
• Last Updated: August 20, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)