Allogeneic Valve Transplantation

Not Applicable

Recruiting

• Conditions: Valve Disease, Heart; Valve Heart Disease; Valve Disease, Aortic
• Interventions: Procedure: Valve transplant

• Registration Number: NCT06387446
• Lead Sponsor: Boston Children's Hospital

Brief Summary

Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

Detailed Description

Heart valves in children and young adults may need replacement or repair. In many children the options for heart valve replacement do not grow as the child grows. A transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. This trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. The study will look at outcomes of valve transplant and any potential side effects.

Study Timeline

• Study First Submitted: 2023-06-21
• Status Verified: 2024-04
• Study First Submitted QC: 2024-04-25
• Last Update Submitted: 2024-04-25
• Study First Posted: 2024-04-29
• Last Update Posted: 2024-04-29
• Study Start: 2024-05-01
• Primary Completion: 2027-06-01
• Study Completion: 2027-06-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 4

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Valve transplantation group	Valve transplant	This arm undergoes Allogeneic Valve transplantation

Primary Outcome Measures

Name	Time	Method
Valve Annulus Growth	One Year	Measurement of valve annulus via echocardiogram, CT scan and MRI. This will be quantified by whether or not the annulus continues to increase in size as the subject grows.
Valve Regurgitation	One year	Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Leaflet Growth	One Year	Measurement of leaflet height via echocardiogram, CT scan and MRI and reviewed by an echocardiologist. This will be analyzed by whether or not the leaflets continue to grow in size, with the subject.

Secondary Outcome Measures

Name	Time	Method
Survival	5 years	The number of patients that survive the initial procedure and long term outcomes.
Ventricular Function	One year	Ventricular function will be visualized using echocardiogram, measured as ejection fraction as well as shortening fraction and will be determined by an echocardiologist. The factors involved will be the symmetrical squeeze of the ventricles, the ejection fraction, ventricular end systolic and diastolic volume with calculation of stroke volume to come to a surrogate of cardiac output.

Trial Locations

Locations (1)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States