Valve Heart DiseaseNCT06387446
Allogeneic Valve Transplantation
A study testing Valve transplant in people with Valve Heart Disease and Valve Disease, Heart, run by Boston Children's Hospital at 1 site in United States.
Trial summary
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve. Read more about this study
- Who is it for?
- Ages 30 days to 50 years
- Conditions the study is for
- Valve Heart Disease, Valve Disease, Heart, Valve Disease, Aortic
- What is being tested?
- Valve transplant
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 days to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Sitaram Emani, MD
About this study
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Read the detailed description
Heart valves in children and young adults may need replacement or repair. In many children the options for heart valve replacement do not grow as the child grows. A transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. This trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. The study will look at outcomes of valve transplant and any potential side effects.
- Being tested
- Valve transplant
- Medical subject headings
- Heart Valve Diseases, Aortic Valve Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Valve transplantProcedure or surgery
Heart valves from an organ donor will be transplanted into recipient
| Study group | Role | What they receive |
|---|---|---|
| Valve transplantation group | Experimental | This arm undergoes Allogeneic Valve transplantation Receives: Procedure: Valve transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Valve Regurgitation
Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Measured: One year
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.
Measured: One Year
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.
Measured: One Year
Secondary outcomes (2)
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.
Measured: One year
Survival
The number of patients that survive the initial procedure and long term outcomes.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 May 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Valve Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Boston Children's HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boston Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sitaram Emani, Boston Children's Hospital
- Investigators
- Sitaram Emani, MD, Principal investigator, Boston Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06387446
- Sponsor's protocol ID
- RB-P00044611
- Status last verified
- Sep 2024
- First submitted
- 21 Jun 2023
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Valve Transplantation
- ClinicalTrials.gov ID
- NCT06387446
- Acronym / sponsor ID
- RB-P00044611
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 4 participants (estimated)
- Lead sponsor
- Boston Children's HospitalUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 29 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
Detailed description
Heart valves in children and young adults may need replacement or repair. In many children the options for heart valve replacement do not grow as the child grows. A transplanted valve may have the option to grow with time and may reduce the need for multiple operations over a lifetime. This trial will study the outcomes of heartfelt transplant in children and young adults undergoing this procedure. The study will look at outcomes of valve transplant and any potential side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Valve transplantation group | Experimental | Procedure: Valve transplantThis arm undergoes Allogeneic Valve transplantation |
Who may qualify
- Ages
- 30 days to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Valve transplantHeart valves from an organ donor will be transplanted into recipient | Procedure or surgery | Valve transplantation group |
Primary outcome
Valve Regurgitation
Time frame: One year
Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Valve Annulus Growth
Time frame: One 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 Growth
Time frame: One 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.
2 secondary outcomes
Ventricular Function
Time frame: One year
Survival
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sitaram Emani, MD principal investigator
Boston Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Valve transplant in people with Valve Heart Disease and Valve Disease, Heart, run by Boston Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sitaram Emani, MD (6173557899, sitaram.emani@cardio.chboston.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Valve Regurgitation (time frame: One year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Sep 2024.