Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome

NCT01736956 | Completed DMC

• 1 other identifier: 12-08688
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Aortic Stenosis; Hypoplastic Left Heart Syndrome

Keywords

aortic stenosis; hypoplastic left heart syndrome; fetal aortic valvuloplasty

Outcome Measures

Primary Outcomes (1)

• 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

  Monthly until birth, and after birth until three years of age

Secondary Outcomes (1)

• Neonatal survival at 365 days of life

  365 days after birth

Other Outcomes (1)

• Neurodevelopmental and functional status

  Birth to 30 months

Study Arms (2)

Fetal Aortic Valvuloplasty

EXPERIMENTAL

Subjects will undergo fetal aortic valvuloplasty

Procedure: Fetal Aortic Valvuloplasty

Control

NO INTERVENTION

Control group. Will receive standard prenatal and postnatal care.

Interventions

Fetal Aortic Valvuloplasty PROCEDURE

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.

Also known as: Fetal balloon aortic valvuloplasty

Fetal Aortic Valvuloplasty

Eligibility Criteria

• Age: 16 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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;
• Short cervix (\< 20mm) measured by cervical ultrasound;
• 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;

Sponsors & Collaborators

• University of California, San Francisco: lead

Study Sites (1)

University of California, San Francisco Fetal Treatment Center

San Francisco, California, 94158, United States

Location

MeSH Terms

Conditions

Aortic Valve Stenosis; Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Heart Defects, Congenital; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Anita Moon-Grady, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 26, 2012
• First Posted: November 29, 2012
• Study Start: October 1, 2012
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: January 9, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)