NCT07132593|Completed
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Sponsor study identifier
observational
17
1 country
1
Study Start
January 1, 2018
Actual (reported)Primary Completion
December 31, 2023
Actual (reported)Study Completion
July 31, 2025
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 31, 2025
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2018
Actual (reported)December 31, 2023
Actual (reported)July 31, 2025
Actual (reported)August 8, 2025
Actual (reported)August 20, 2025
Actual (reported)composite endpoint
all-cause mortality or cardiac reoperation
up to 5 years
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
Patients underwent cardiac fibroma resection and following ventricular reconstruction with the Sandwich 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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
patients underwent cardiac fibroma resection followed by ventricular reconstruction with the Sandwich Procedure at our institution
Pediatric Cardiac Surgery Center, Fuwai Hospital
Beijing, Beijing Municipality, 100037, China
17 participants (actual enrollment reported by the registry).
First Submitted
August 8, 2025
First Posted
August 20, 2025
Study Start
January 1, 2018
Actual (reported)Contact the study team to confirm eligibility.
Primary Completion
December 31, 2023
Actual (reported)Study Completion
July 31, 2025
Actual (reported)Last Updated
August 20, 2025
Record last verified: 2025-08
The data underlying this article cannot be shared publicly for the privacy of individuals that participated in the study.
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Source: ClinicalTrials.gov.
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