Allogeneic Valve Transplantation for Valve Heart Disease

This study is testing a procedure called "Valve transplant." This means you would receive a heart valve from an organ donor. The goal is to see if these transplanted valves can grow over time, potentially reducing the need for multiple surgeries, especially in children. The study is for children and young adults (ages 30 days to 50 years) who need a new heart valve and have limited other options. Researchers will measure how well the valve works (Valve Regurgitation), and if the valve and its surrounding area (Valve Annulus, Leaflet) grow, all at one year after the transplant. The current recruitment status is unclear.

Study design: This is an interventional study with a planned enrollment of 4 participants. It is designed to evaluate the outcomes of heart valve transplantation.
What's involved: Not specified in the trial record.
Compensation: Not stated in the trial record.
Follow-up: Participants will be followed for at least one year to measure valve function and growth.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Allogeneic Valve Transplantation

Recruiting

NAAges 30–50InterventionalTreatment

Boston Children's Hospital

~4 participants

Updated 2024-09-24 on ClinicalTrials.gov

What's tested:Valve transplant

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Valve Regurgitation

Measured over One year

+2 more outcomes measured

Conditions

Valve Heart Disease

Valve Disease, Heart

Valve Disease, Aortic

Where it's being run

1 sites across 1 states

Massachusetts1

Study leadership

Sitaram Emani, MD · PRINCIPAL_INVESTIGATOR · Boston Children's Hospital

Who to contact

Sitaram Emani, MD

[email protected]

6173557899

Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime

Eligibility criteria

Inclusion

Patients requiring aortic, pulmonary, mitral or tricuspid valve replacement.

Pediatric patients 30 days or older and \< 18 years, and adult patients 18-50 yrs.

Insufficient options are available for valve replacement

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

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

What this trial measures

Valve RegurgitationOne year
Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Valve Annulus GrowthOne Year
Measurement of valve annulus via echocardiogram, CT scan and MRI. This will be quantified by whether or not the annulus continues to increase in size as the subject grows.
Leaflet GrowthOne Year
Measurement of leaflet height via echocardiogram, CT scan and MRI and reviewed by an echocardiologist. This will be analyzed by whether or not the leaflets continue to grow in size, with the subject.

Trialytics