| NCT ID | NCT06387446 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Boston Children's Hospital |
| Condition | Valve Heart Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 4 participants |
| Start Date | 2024-05-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 4 participants in total. It began in 2024-05-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Eligibility Criteria
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
Contact & Investigator
Sitaram Emani, MD
PRINCIPAL INVESTIGATOR
Boston Children's Hospital
Frequently Asked Questions
Who can join the NCT06387446 clinical trial?
This trial is open to participants of all sexes, aged 30 Days or older, up to 50 Years, studying Valve Heart Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06387446 currently recruiting?
Yes, NCT06387446 is actively recruiting participants. Contact the research team at sitaram.emani@cardio.chboston.org for enrollment information.
Where is the NCT06387446 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT06387446 clinical trial?
NCT06387446 is sponsored by Boston Children's Hospital. The principal investigator is Sitaram Emani, MD at Boston Children's Hospital. The trial plans to enroll 4 participants.