NCT06387446 · Boston Children's Hospital
Allogeneic Valve Transplantation
What this study is about
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
View original scientific description
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Boston, Massachusetts
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 24, 2024 · Source of record for eligibility and locations