Allogeneic Valve Transplantation

Boston Children's Hospital

Status

Enrolling

Conditions

Valve Heart Disease

Valve Disease, Aortic

Valve Disease, Heart

Treatments

Procedure: Valve transplant

Study type

Interventional

Funder types

Other

Identifiers

NCT06387446

RB-P00044611

Details and patient eligibility

About

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

Full 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.

Enrollment

4 estimated patients

Sex

All

Ages

30 days to 50 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

Patients requiring aortic, pulmonary, mitral or tricuspid 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

Exclusion Criteria

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