Actively Recruiting
Allogeneic Valve Transplantation
Led by Boston Children's Hospital · Updated on 2024-09-24
4
Participants Needed
1
Research Sites
160 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
CONDITIONS
Official Title
Allogeneic Valve Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement
- Pediatric patients 30 days or older and under 18 years, and adult patients 18 to 50 years
- Particularly patients with significant growth potential
- Insufficient options available for valve replacement, including patients at risk of immunogenic bio-prosthetic valve failure
- Discussion with patient/family about durable valve option rather than traditional prosthesis
- ABO compatible
- Patient and family able to travel to the hospital within 48 hours or within the organ procurement organization
- Patients able to maintain follow-up at the hospital during the study
- Patients able to provide medical record authorization for 5 year follow-up
You will not qualify if you...
- Age under 30 days
- Irreversible multisystem organ failure or conditions making transplant survival unlikely
- Progressive systemic disease with early mortality (genetic, metabolic, idiopathic, syndromic)
- Morbid obesity (BMI over 35)
- Diabetes with end-organ damage
- Severe chromosomal, neurologic, or syndromic abnormalities
- Immunocompromised conditions (e.g., DiGeorge, SCID)
- 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 care
- Recent history of illicit drug, tobacco, or alcohol abuse despite attempts to stop
- Evidence of large stroke with high hemorrhagic risk
- Heart transplant recipient
- Patients unable to follow-up during the initial 6 month period
- Patients unable to provide medical record authorization for 5 years
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Sitaram Emani, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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