Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
4 participants
INTERVENTIONAL
2024-05-01
2027-06-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Valve transplantation group
This arm undergoes Allogeneic Valve transplantation
Valve transplant
Heart valves from an organ donor will be transplanted into recipient
Interventions
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Valve transplant
Heart valves from an organ donor will be transplanted into recipient
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
30 Days
50 Years
ALL
No
Sponsors
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Boston Children's Hospital
OTHER
Responsible Party
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Sitaram Emani
Associate Professor of Surgery
Principal Investigators
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Sitaram Emani, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Locations
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Boston Children's Hospital
Boston, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Sitaram Emani, MD
Role: primary
Other Identifiers
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RB-P00044611
Identifier Type: -
Identifier Source: org_study_id
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