Allogeneic Valve Transplantation

Valve Heart Disease Clinical Trial

Official title:

Allogeneic Valve Transplantation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06387446
• Other study ID #: RB-P00044611
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: June 1, 2027

Study information

• Verified date: April 2024
• Source: Boston Children's Hospital
• Contact: Sitaram Emani, MD
• Phone: 6173557899
• Email: sitaram.emani[@]cardio.chboston.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 4
• Est. completion date: June 1, 2027
• Est. primary completion date: June 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Days to 50 Years

Eligibility

The proposed indications include:

• Patients requiring aortic or pulmonary valve replacement.
• Pediatric patients 30 days or older and < 18 years, and adult patients 18-50 yrs. o Particularly patients with significant growth potential
• Insufficient options are available for valve replacement o Patients at risk of immunogenic bio-prosthetic valve failure
• Discussion with patient /family - option for durable valve rather than traditional prosthesis
• ABO compatible
• Patient and family able to travel to BCH within 48 hour time frame or within our organ procurement organization
• Patients that are able to maintain follow-up at BCH during the duration of the study
• Patients that are able to provide medical record authorization for 5 year follow-up

The proposed contraindications include:

• Age < 30 days
• Irreversible multisystem organ failure; or additive effects of the multiple systems affected making transplant survival unlikely
• Progressive systemic disease with early mortality (genetic/metabolic, idiopathic, syndromic)
• Morbid obesity (BMI>35)
• Diabetes mellitus with evidence of end-organ damage
• Severe chromosomal, neurologic or syndromic abnormalities
• Immunocompromised condition (DiGeorge, SCID etc.)
• Active infection
• History of endocarditis
• HIV or chronic hepatitis B or C infection
• Malignancy within 5 years prior to transplant
• Severe renal or liver failure
• Inadequate social support for post-transplant management
• Recent history of illicit drug, tobacco or alcohol abuse despite trials/assistance to stop behavior
• Evidence of large stroke with high risk for hemorrhagic conversion
• Heart transplant recipient
• Patients that are unable to follow-up during the initial 6 month window
• Patients that are unable to provide medical record authorization for 5 years

Related Conditions & MeSH terms

• Aortic Diseases
• Aortic Valve Disease
• Heart Diseases
• Heart Valve Diseases
• Valve Disease, Heart
• Valve Heart Disease

Intervention

Procedure:
• Valve transplant
Heart valves from an organ donor will be transplanted into recipient

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Boston Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Valve Regurgitation	Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.	One year
Primary	Valve Annulus Growth	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.	One Year
Primary	Leaflet Growth	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.	One Year
Secondary	Ventricular Function	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.	One year
Secondary	Survival	The number of patients that survive the initial procedure and long term outcomes.	5 years