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NCT07132593Completed

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

Source: ClinicalTrials.gov · Last updated 20 Aug 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
17 (actual)
First submitted
8 Aug 2025
Start date
1 Jan 2018
Primary completion date
31 Dec 2023
Lead sponsor
China National Center for Cardiovascular Diseases
NCT number
NCT07132593

What you commit to

  • Study type: Observational
  • Participants enrolled: 17
  • From 1 Jan 2018 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • the final pathological diagnosis indicated other than cardiac fibroma

Other

  • the final pathological diagnosis indicated metastatic tumors
  • incomplete clinical or follow-up data

Who the study is looking for

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

Age in the registry: - to 14 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Pediatric Cardiac Surgery Center, Fuwai Hospital
Coordinator of this site? Confirm its status
BeijingChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.