Health TrialsbyHealthPanel

Allogeneic Valve Transplantation

ConditionsValve Heart DiseaseValve Disease, HeartValve Disease, Aortic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30-50
SponsorBoston Children's Hospital

About this trial

Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • Valve transplant

    Procedure/Surgery

    Heart valves from an organ donor will be transplanted into recipient

Treatment groups

4 Participants
are divided into 1 treatment group
Group A: Valve transplantation groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Valve Regurgitation

Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.

Time frame
One year
2

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.

Time frame
One Year
3

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.

Time frame
One Year

Secondary outcomes

1

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.

Time frame
One year
2

Survival

The number of patients that survive the initial procedure and long term outcomes.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Boston Children's Hospital

Lead sponsor

Source ClinicalTrials.gov
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