Aortic StenosisNCT01736956
Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome
A study testing Fetal Aortic Valvuloplasty in people with Aortic Stenosis and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco at 1 site in United States.
Trial summary
For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve fetal growth of left heart structures and thus improve potential for biventricular repair strategies after birth. Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Aortic Stenosis, Hypoplastic Left Heart Syndrome
- What is being tested?
- Fetal Aortic Valvuloplasty
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2012to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Pregnant woman carrying a fetus with normal cardiac segmental anatomy and severe aortic stenosis as defined by:
- Dysplastic/stenotic aortic valve with forward flow, with or without gradient, and no significant insufficiency
- If mitral insufficiency (incomplete closure of the mitral valve)is present, left ventricle systolic pressure calculation must be ≥ a normal systemic blood pressure (BP) for gestational age
- Retrograde aortic arch flow
- Left to right atrial shunting
- Left ventricle length no less than 90% the length of the right ventricle
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- Maternal age ≥ 16 years of age;
- Gestational age: 17 0/7-30 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound. (Aortic valve dilation procedure cannot be performed until 18 0/7 weeks);
- Normal karyotype with written confirmation of results. Results by fluorescence in situ hybridization (FISH) for aneuploidy will be acceptable if the patient is at 24 weeks or more; non-invasive testing is acceptable (maternal serum testing for cell-free fetal DNA, currently commercially available).
- Singleton pregnancy;
- Able to travel to study site for study evaluation, procedures, and visits;
- Support person to travel and stay with patient (support person will be required to sign the support person consent form);
- Has received pre-authorization for insurance for fetal intervention or has the ability to self-pay for study treatment
Who cannot join
- Failure to meet all inclusion criteria;
- Multi-fetal pregnancy;
- Insulin dependent pregestational diabetes;
- Fetal anomaly not related to aortic stenosis. A detailed fetal anatomic ultrasound will be conducted before consideration for the study and if the finding is abnormal, the patient will be excluded;
- Current or planned cerclage or documented history of incompetent cervix;
- Placenta previa or placental abruption;
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- Short cervix (< 20mm) measured by cervical ultrasound;
- Previous spontaneous delivery prior to 37 weeks of a singleton pregnancy. If the study candidate had intact membranes and was induced, this is not considered spontaneous. Stillbirths prior to 37 weeks are not exclusionary.
- Obesity as defined by body mass index of 35 or greater;
- Maternal-fetal Rh isoimmunization, Kell sensitization or a history of neonatal alloimmune thrombocytopenia;
- Positive maternal HIV status. This is due to the increased risk of transmission to the fetus during the maternal-fetal procedure. If the patient's HIV status is unknown, the patient must be tested and found to have negative results before she can be entered into the fetal treatment group;
- Known Hepatitis C positivity. If the patient's Hepatitis C status is unknown, she does not need to be screened;
- Other maternal medical condition which is a contraindication to surgery or general anesthesia, such as asthma, cardiac disease, the refusal of a blood transfusion, or a previous hysterotomy in the active segment of the uterus;
- Patient does not have a support person (e.g., husband, partner, mother), or that support person is unwilling to sign the support person consent form;
- Inability to comply with the travel and follow-up requirements of the study;
- Patient does not meet other psychosocial criteria to handle the implications of the study;
- Participation in another intervention study that influences maternal and fetal morbidity and mortality;
- Maternal hypertension which would increase the risk of preeclampsia or preterm delivery (including, but not limited to: uncontrolled hypertension, chronic hypertension with end organ damage and new onset hypertension in current pregnancy).
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, San Francisco Fetal Treatment Center
San Francisco, California, 94158
About this study
For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve fetal growth of left heart structures and thus improve potential for biventricular repair strategies after birth.
Read the detailed description
Fetal aortic stenosis is an anatomically simple birth defect in which there is partial blockage of the aortic valve, limiting blood flow out of the left side of the heart. If the blockage becomes severe in fetal life, the left heart structures may stop growing and the baby may be born with hypoplastic left heart syndrome (HLHS), a lethal condition without neonatal heart surgery or heart transplantation. Standard treatment for babies born with HLHS includes three major cardiac operations before the age of 6 years. Postnatal outcomes for HLHS are uncertain and vary with patient; however, the few adult survivors are currently suffering substantial medical problems, including a high incidence of neurologic problems. For fetuses with severe obstruction, fetal intervention may improve outcomes by increasing flow through the left heart, thus improving left heart function and encouraging continued growth of the left heart structures. If fetal intervention can preserve left heart function and growth, this should provide a better prognosis for the baby and allow for biventricular repair strategies after birth.
This research study is a prospective, non-randomized clinical trial of 30 patients that will assess the safety and efficacy of in utero percutaneous balloon dilation of fetal aortic valve with severe stenosis. This technique has been successfully used to perform postnatal aortic valve dilations for several decades, but has had limited application and study in utero.
Pregnant women carrying a fetus diagnosed with severe aortic stenosis will be referred to the University of California, San Francisco Fetal Treatment Center for evaluation, initial screening and counseling. If all fetal and maternal inclusion criteria are met, the balloon aortic valvuloplasty operation will be offered to the pregnant woman. Patients who do not meet study eligibility or decline prenatal intervention will be offered the option to enroll as a study control.
- Conditions
- Aortic Stenosis, Hypoplastic Left Heart Syndrome
- Being tested
- Fetal Aortic Valvuloplasty
- Keywords
- aortic stenosis, hypoplastic left heart syndrome, fetal aortic valvuloplasty
- Medical subject headings
- Aortic Valve Stenosis, Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Aortic ValvuloplastyProcedure or surgery
Also called Fetal balloon aortic valvuloplasty
Fetuses in the intervention group will undergo in utero balloon aortic valvuloplasty via a transuterine, perventricular approach. Fetuses in the control group will have no invasive intervention while in utero.
| Study group | Role | What they receive |
|---|---|---|
| Fetal Aortic Valvuloplasty | Experimental | Subjects will undergo fetal aortic valvuloplasty Receives: Procedure: Fetal Aortic Valvuloplasty |
| Control | No intervention | Control group. Will receive standard prenatal and postnatal care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improved fetal mitral valve and left ventricular growth
The primary outcome variable is fetal mitral valve and left ventricular growth due to successful balloon dilation, as determined by serial echocardiographic measurements
Measured: Monthly until birth, and after birth until three years of age
Secondary outcomes (1)
Neonatal survival at 365 days of life
Measured: 365 days after birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2012 (estimated)
- Study startOct 2012
- Primary completionOct 2022
- Study completionOct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Moon-Grady, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01736956
- Sponsor's protocol ID
- 12-08688
- Status last verified
- Jan 2023
- First submitted
- 26 Nov 2012
- Last updated
- 9 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome
- ClinicalTrials.gov ID
- NCT01736956
- Acronym / sponsor ID
- 12-08688
- Conditions
- Aortic Stenosis, Hypoplastic Left Heart Syndrome
- Keywords
- aortic stenosis, hypoplastic left heart syndrome, fetal aortic valvuloplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Oct 2022 (actual)
- Study completion
- Oct 2022 (actual)
- First posted
- 29 Nov 2012 (estimated)
- 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.
For fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve fetal growth of left heart structures and thus improve potential for biventricular repair strategies after birth.
Detailed description
Fetal aortic stenosis is an anatomically simple birth defect in which there is partial blockage of the aortic valve, limiting blood flow out of the left side of the heart. If the blockage becomes severe in fetal life, the left heart structures may stop growing and the baby may be born with hypoplastic left heart syndrome (HLHS), a lethal condition without neonatal heart surgery or heart transplantation. Standard treatment for babies born with HLHS includes three major cardiac operations before the age of 6 years. Postnatal outcomes for HLHS are uncertain and vary with patient; however, the few adult survivors are currently suffering substantial medical problems, including a high incidence of neurologic problems. For fetuses with severe obstruction, fetal intervention may improve outcomes by increasing flow through the left heart, thus improving left heart function and encouraging continued growth of the left heart structures. If fetal intervention can preserve left heart function and growth, this should provide a better prognosis for the baby and allow for biventricular repair strategies after birth.
This research study is a prospective, non-randomized clinical trial of 30 patients that will assess the safety and efficacy of in utero percutaneous balloon dilation of fetal aortic valve with severe stenosis. This technique has been successfully used to perform postnatal aortic valve dilations for several decades, but has had limited application and study in utero.
Pregnant women carrying a fetus diagnosed with severe aortic stenosis will be referred to the University of California, San Francisco Fetal Treatment Center for evaluation, initial screening and counseling. If all fetal and maternal inclusion criteria are met, the balloon aortic valvuloplasty operation will be offered to the pregnant woman. Patients who do not meet study eligibility or decline prenatal intervention will be offered the option to enroll as a study control.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal Aortic Valvuloplasty | Experimental | Procedure: Fetal Aortic ValvuloplastySubjects will undergo fetal aortic valvuloplasty |
| Control | No intervention | –Control group. Will receive standard prenatal and postnatal care. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (13 listed)
- Pregnant woman carrying a fetus with normal cardiac segmental anatomy and severe aortic stenosis as defined by:
- Maternal age ≥ 16 years of age;
- Gestational age: 17 0/7-30 6/7 weeks' gestation as determined by clinical information and evaluation of first ultrasound. (Aortic valve dilation procedure cannot be performed until 18 0/7 weeks);
- Normal karyotype with written confirmation of results. Results by fluorescence in situ hybridization (FISH) for aneuploidy will be acceptable if the patient is at 24 weeks or more; non-invasive testing is acceptable (maternal serum testing for cell-free fetal DNA, currently commercially available).
- Singleton pregnancy;
Key exclusion criteria (18 listed)
- Failure to meet all inclusion criteria;
- Multi-fetal pregnancy;
- Insulin dependent pregestational diabetes;
- Fetal anomaly not related to aortic stenosis. A detailed fetal anatomic ultrasound will be conducted before consideration for the study and if the finding is abnormal, the patient will be excluded;
- Current or planned cerclage or documented history of incompetent cervix;
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 |
|---|---|---|
| Fetal Aortic ValvuloplastyAlso: Fetal balloon aortic valvuloplastyFetuses in the intervention group will undergo in utero balloon aortic valvuloplasty via a transuterine, perventricular approach. Fetuses in the control group will have no invasive intervention while in utero. | Procedure or surgery | Fetal Aortic Valvuloplasty |
Primary outcome
Improved fetal mitral valve and left ventricular growth
Time frame: Monthly until birth, and after birth until three years of age
The primary outcome variable is fetal mitral valve and left ventricular growth due to successful balloon dilation, as determined by serial echocardiographic measurements
1 secondary outcome
Neonatal survival at 365 days of life
Time frame: 365 days after birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2023.
- 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. This study is not recruiting at the moment.
Anita Moon-Grady, MD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Aortic Valvuloplasty in people with Aortic Stenosis and Hypoplastic Left Heart Syndrome, run by University of California, San Francisco 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 13 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: finished, as of the sponsor's last update on 9 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improved fetal mitral valve and left ventricular growth (time frame: Monthly until birth, and after birth until three years of age). 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 9 Jan 2023.