Valve Disease, Aortic, Valve Disease, Heart, Valve Heart Disease
Conditions
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.
Interventions
PROCEDUREValve transplant
Heart valves from an organ donor will be transplanted into recipient
Sponsors
Boston Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Days to 50 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Valve Regurgitation | One year | Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist. |
| Valve Annulus Growth | One Year | Measurement of valve annulus via echocardiogram, CT scan and MRI. This will be quantified by whether or not the annulus continues to increase in size as the subject grows. |
| Leaflet Growth | One Year | Measurement of leaflet height via echocardiogram, CT scan and MRI and reviewed by an echocardiologist. This will be analyzed by whether or not the leaflets continue to grow in size, with the subject. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Ventricular Function | One year | Ventricular function will be visualized using echocardiogram, measured as ejection fraction as well as shortening fraction and will be determined by an echocardiologist. The factors involved will be the symmetrical squeeze of the ventricles, the ejection fraction, ventricular end systolic and diastolic volume with calculation of stroke volume to come to a surrogate of cardiac output. |
| Survival | 5 years | The number of patients that survive the initial procedure and long term outcomes. |
Countries
United States
Contacts
Primary ContactSitaram Emani, MD
Outcome results
None listed