Summary
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
Recruitment Status
RECRUITING
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
The proposed indications include:
* Patients requiring aortic or pulmonary 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
The proposed contraindications include:
* 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
Intervention
Intervention Type
Intervention Name
PROCEDURE
Valve transplant
Phase
NA
Gender
ALL
Min Age
30 Days
Max Age
50 Years
Download Date
2024-04-29
Principal Investigator
N/A
Primary Contact Information
sitaram.emani@cardio.chboston.org
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For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: