Actively Recruiting
Allogeneic Valve Transplantation for Children and Adults Needing Heart Valve Replacement
Led by Boston Children's Hospital · Updated on 2024-09-24
4
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Heart valves in children and young adults may need replacement or repair, but many current options do not grow as the patient grows. This research aims to study the outcomes of allogeneic heart valve transplantation, where valves from organ donors are implanted into patients needing new heart valves. The trial focuses on children and adults who require valve replacement and may have limited options due to growth potential or risk of prosthetic valve failure. Participants will receive a transplanted heart valve from an organ donor, specifically for aortic, pulmonary, mitral, or tricuspid valve replacement. The procedure involves implanting a valve that may grow with the patient over time, potentially reducing the need for multiple surgeries. This is a single-arm interventional trial without masking or blinding, and it includes follow-up of valve function and growth over one year and survival over five years. During the study, participants will be monitored at Boston Children's Hospital for valve regurgitation, valve annulus growth, and leaflet growth at one year. Additional assessments will include ventricular function and survival up to five years. Patients and their families must be able to travel quickly for the transplant and maintain follow-up care, including medical record authorization for five years. The total commitment involves ongoing monitoring to evaluate the transplanted valve's performance and any potential side effects.
CONDITIONS
Brief 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.
- Patients at risk of immunogenic bio-prosthetic valve failure.
- Discussion with patient/family about option for durable valve instead of traditional prosthesis.
- ABO compatible.
- Patient and family able to travel to Boston Children's Hospital within 48 hours or within organ procurement organization.
- Patients able to maintain follow-up at Boston Children's 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 multiple system effects 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 condition (such as DiGeorge syndrome, 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 management.
- Recent illicit drug, tobacco, or alcohol abuse despite attempts to stop.
- Evidence of large stroke with high risk for bleeding.
- Heart transplant recipient.
- Unable to follow-up during initial 6 months.
- Unable to provide medical record authorization for 5 years.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
screening and enrollment visit
Duration - Up to hospital discharge
Participants undergo allogeneic heart valve transplantation and receive immediate post-operative care.
1 surgical procedure and hospitalization period
Duration - Up to 1 year
Participants are monitored for valve function, growth, and any potential side effects after the transplant.
Regular follow-up visits throughout the year
Duration - Up to 5 years
Participants are followed for survival and overall health outcomes after transplantation.
Periodic visits over 5 years
Trial Site Locations
Total: 1 location
1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
Research Team
S
Sitaram Emani, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here