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Allogeneic Valve Transplantation

RECRUITINGN/ASponsored by Boston Children's Hospital
Actively Recruiting
PhaseN/A
SponsorBoston Children's Hospital
Started2024-05-01
Est. completion2027-06-01
Eligibility
Age30 Days – 50 Years
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06387446

Summary

Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

Eligibility

Age: 30 Days – 50 YearsHealthy volunteers accepted
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

Conditions4

Heart DiseaseValve Disease, AorticValve Disease, HeartValve Heart Disease

Locations1 site

Boston Children's Hospital
Boston, Massachusetts, 02115
Sitaram Emani, MD

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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