Transplanting heart valves from donors into patients who need them

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves the transplantation of heart valves from organ donors into pediatric and young adult patients who require valve replacement. The focus is on patients whose heart valves may not grow with them, offering a potential solution that could reduce the need for multiple surgeries over their lifetime. The trial will evaluate the outcomes of these valve transplants, including any side effects experienced by the patients. The goal is to provide a durable valve option that can accommodate growth in younger patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting

Study contacts

• Principal investigator: Sitaram Emani, MD — Boston Children's Hospital
• Study coordinator: Sitaram Emani, MD
• Email: sitaram.emani@cardio.chboston.org
• Phone: 6173557899

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.