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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07132593
Enrollment
17
Registered
2025-08-20
Start date
2018-01-01
Completion date
2025-07-31
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Tumor

Keywords

congenital heart disease, cardiac tumor, surgical technique

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.

Interventions

PROCEDUREventricular reconstruction

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.

Sponsors

China National Center for Cardiovascular Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
OTHER
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
No minimum to 14 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
composite endpointup to 5 yearsall-cause mortality or cardiac reoperation

Secondary

MeasureTime frameDescription
ventricular failureup to 5 yearsleft ventricular ejection fraction (LVEF) \< 55% or right ventricular fractional area change (RVFAC) \< 45% by echocardiography
ventricular aneurysmup to 5 yearsnewly formed segmental dyskinesia with localized dilation
malignant arrhythmiaup to 5 yearssustained ventricular tachycardia, ventricular fibrillation, or frequent polymorphic premature ventricular contractions requiring medical intervention
Heart blockup to 5 yearsany new onset of high-degree atrioventricular block (Mobitz II or complete AVB), as well as complete left bundle branch block (CLBBB) by ECG
severe perioperative complicationsbefore dischargeincluding low cardiac output syndrome \[cardiac index \< 2.0 L/(min·m2)\], delayed sternal closure, prolonged invasive mechanical ventilation (≥ 7 days) and need for extra-corporeal membrane oxygenation (ECMO)

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026