Allogeneic Valve Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Valve transplant.
- Who it may be relevant to
- Registry conditions: Valve Heart Disease, Valve Disease, Heart, Valve Disease, Aortic. Basic parameters: 30 Days — 50 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Procedure Valve transplant
Heart valves from an organ donor will be transplanted into recipient
Primary outcome measures
- Valve Regurgitation [Time frame: One year]
- Valve Annulus Growth [Time frame: One Year]
- Leaflet Growth [Time frame: One Year]
Secondary outcome measures (2)
- Ventricular Function [Time frame: One year]
- Survival [Time frame: 5 years]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Boston Children's Hospital — Boston
Identifiers
NCT: NCT06387446 · RB-P00044611