No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
30 Days – 50
Sex
Any
Study type
Interventional
Purpose
Treatment
Participants needed
4 (estimated)
Sponsor
Boston Children's Hospital · Other
Who this trial is looking for
This trial is looking for patients who need a new heart valve and might benefit from using valves from donated hearts. Taking part involves potential travel to the transplant center and staying in touch for follow-up care.
Are You a Good Fit for This Trial?
Rules you outHIVChronic hepatitis BChronic hepatitis CMalignancy
You may be able to join if
I need a replacement for my aortic, pulmonary, mitral, or tricuspid valve.
I am a child aged 30 days or older, or I am between 18 and 50 years old.
I do not have enough options for valve replacement.
I am able to travel to the transplant center within 48 hours.
I can maintain follow-up appointments during the trial.
I can provide authorization for my medical records for 5 years.
You may not be able to join if
I am under 30 days old.
I have severe organ failure affecting multiple systems.
I have a serious progressive disease that may lead to early death.
I have a BMI over 35.
I have diabetes with damage to my organs.
I am immunocompromised due to a medical condition.
I have an active infection.
I have had a history of endocarditis.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Trial Locations
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City
State
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Status
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 replacem…
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
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