RecruitingNot ApplicableNCT06387446

Allogeneic Valve Transplantation

Sponsor

Boston Children's Hospital

Enrollment

4 participants

Start Date

May 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 30 DaysMax Age: 50 Years

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

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

PROCEDUREValve transplant

Heart valves from an organ donor will be transplanted into recipient

Boston Children's Hospital

Boston, Massachusetts, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

NCT06387446