Valve Heart Disease Clinical Trial
Official title:
Allogeneic Valve Transplantation
NCT number | NCT06387446 |
Other study ID # | RB-P00044611 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2024 |
Est. completion date | June 1, 2027 |
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Status | Recruiting |
Enrollment | 4 |
Est. completion date | June 1, 2027 |
Est. primary completion date | June 1, 2027 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Days to 50 Years |
Eligibility | The proposed indications include: - Patients requiring aortic or pulmonary 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 The proposed contraindications include: - 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 |
Country | Name | City | State |
---|---|---|---|
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Valve Regurgitation | Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist. | One year | |
Primary | Valve Annulus Growth | 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. | One Year | |
Primary | Leaflet Growth | 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. | One Year | |
Secondary | Ventricular Function | Ventricular function will be visualized using echocardiogram, measured as ejection fraction as well as shortening fraction and will be determined by an echocardiologist. The factors involved will be the symmetrical squeeze of the ventricles, the ejection fraction, ventricular end systolic and diastolic volume with calculation of stroke volume to come to a surrogate of cardiac output. | One year | |
Secondary | Survival | The number of patients that survive the initial procedure and long term outcomes. | 5 years |
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