An interventional study of Valve transplant in Valve Heart Disease, Valve Disease, Heart and Valve Disease, Aortic, sponsored by Boston Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 30 Days to 50 Years. Per ClinicalTrials.gov, last updated 2024-09-24.
Sponsored by Boston Children's Hospital · Not applicable, Interventional, and Treatment
Among 47 studies in Aortic Valve Disease with a site in United States — 12 open to participants now, 23 under way, none of them phase 3. Aortic Valve Disease · United States.
Among the 47 studies in Aortic Valve Disease with a site in United States, this one is the 29th largest by planned enrollment of the 31 interventional ones that give a count, is one of 5 that started in 2024, is one of 27 with no phase, reaches primary completion later than 15 of the 22 other live ones, and was the 36th registered.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
Browse Aortic Valve Disease studies →12 of the 47 studies in Aortic Valve Disease with a site in United States are open now. Recruiting first, the newest first:
EmStop Inc · Sites in United States
Columbia University · Sites in United States
EnCompass Technologies, Inc. · Sites in United States, Australia
University of Colorado, Denver · Sites in United States
Wake Forest University Health Sciences · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 46 Aortic Valve Disease studies recruiting now, 34 (74%) set no upper age limit and 5 (11%) stop at 75 or younger; 4 take children under 18; 3 take healthy volunteers.
This study: 30 Days to 50 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
47 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 2 1 · Phase 3 2 · Phase 4 2
First in 1998; this study’s year is marked. 5 started in 2024.
This study's planned enrollment of 4 is below the median of 111 across 125 interventional studies indexed under Aortic Valve Disease.
Median enrollment 190 across the 31 interventional studies, 109 across the 16 observational. Of the 23 that completed or were terminated, 11 (48%) have results posted.
This tab as a report to print or save as PDF → With an account.
28 of 47 have an industry lead sponsor. The 10 most frequent:
Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Boston Children's Hospital has 1 study filed under Aortic Valve Disease — fewer than ten, so there is no comparison to draw.
9 of the studies in Aortic Valve Disease with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06506903Medtronic Cardiac SurgeryAvalus Ultra Post-Approval Study (PAS) | 2026-11 |
| NCT06689839EnCompass Technologies, Inc.Trial of the F2 Filter and Delivery System for Embolic Protection During TAVR | 2026-12 |
| NCT02744677Edwards LifesciencesCOMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve Dysfunction | 2026-12 |
| NCT06352671Baylor Research InstituteProspective Long-Term Outcomes of a Standardized Ross Procedure | 2026-12-01 |
| NCT05932615Abbott Medical DevicesENVISION IDE Trial: Safety and Effectiveness of NAVITOR in Transcatheter Aortic Valve Implantation | 2027-04 |
Among the 47 studies in Aortic Valve Disease with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
Valves will be taken from hearts donated by organ donors, and implanted into patients who need a new heart valve.
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.
234 studies on the registry are indexed under Aortic Valve Disease; 70 are open to participants now.
This study's planned enrollment of 4 is below the median of 111 across 125 interventional studies indexed under Aortic Valve Disease.
Browse Aortic Valve Disease studies →Boston Children's Hospital is the lead sponsor of 608 studies on the registry; 147 are open to participants now.
Of its 32 completed or terminated interventional studies of FDA-regulated products, 19 (59%) have results posted.
Compared within Aortic Valve Disease, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Heart Valve Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
This arm undergoes Allogeneic Valve transplantation
Procedure: Valve transplant
Heart valves from an organ donor will be transplanted into recipient
Valve Regurgitation
Heart valve regurgitation by echocardiogram. The degree of regurgitation is read and quantified by an echocardiologist.
Time frame: 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.
Time frame: 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.
Time frame: One Year
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
Survival
The number of patients that survive the initial procedure and long term outcomes.
Time frame: 5 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jun 2027, 37 months after the start.
Of 61 interventional studies with no phase under Aortic Valve Disease, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 61. This study's planned 37 months is close to that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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