Allogeneic Valve Transplantation
Purpose
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Conditions
- Valve Heart Disease
- Valve Disease, Heart
- Valve Disease, Aortic
Eligibility
- Eligible Ages
- Between 30 Days and 50 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Valve transplantation group |
This arm undergoes Allogeneic Valve transplantation |
|
Recruiting Locations
Boston Children's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Contact:
Sitaram Emani, MD
Sitaram Emani, MD
More Details
- Status
- Recruiting
- Sponsor
- Boston Children's Hospital
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.