Clinical trial · Observational
A Retrospective, Observational, and Descriptive Study of Pediatric Cardiac Fibroma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cardiac Tumor | Heart Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ventricular reconstruction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Surgical group
- description
- Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich Procedure.
- interventionNames
- Procedure: ventricular reconstruction
Primary outcomes (1)
- measure
- composite endpoint
- timeFrame
- up to 5 years
- description
- all-cause mortality or cardiac reoperation
Secondary outcomes (5)
- measure
- ventricular failure
- timeFrame
- up to 5 years
- description
- left ventricular ejection fraction (LVEF) \< 55% or right ventricular fractional area change (RVFAC) \< 45% by echocardiography
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 14 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available