Clinical trial NCT06387446: Allogeneic Valve Transplantation
Official title: Allogeneic Valve Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Valve Heart Disease
Valve Disease, Heart
Valve Disease, Aortic
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2024-04-29
Enrollment: 4
Sex: ALL
Minimum age (years): 30
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Valve Regurgitation
timeFrame: One year
measure: Valve Annulus Growth
timeFrame: One Year
measure: Leaflet Growth
timeFrame: One Year
Secondary outcomes:
measure: Ventricular Function
timeFrame: One year
measure: Survival
timeFrame: 5 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Sitaram Emani, MD
role: PRINCIPAL_INVESTIGATOR
References: