Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome
Hypoplastic Left Heart Syndrome
Procedure: Fetal Aortic Valvuloplasty
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome|
- Improved fetal mitral valve and left ventricular growth [ Time Frame: Monthly until birth, and after birth until three years of age ] [ Designated as safety issue: No ]The primary outcome variable is fetal mitral valve and left ventricular growth due to successful balloon dilation, as determined by serial echocardiographic measurements
- Neonatal survival at 365 days of life [ Time Frame: 365 days after birth ] [ Designated as safety issue: No ]
- Neurodevelopmental and functional status [ Time Frame: Birth to 30 months ] [ Designated as safety issue: No ]Neurodevelopmental and functional status at 12 and 30 months of life, as determined by physical exam, echocardiogram, neuro-developmental testing, and hearing testing.
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||October 2017|
|Estimated Primary Completion Date:||October 2017 (Final data collection date for primary outcome measure)|
Experimental: Fetal Aortic Valvuloplasty
Subjects will undergo fetal aortic valvuloplasty
Procedure: Fetal 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.
Other Name: Fetal balloon aortic valvuloplasty
No Intervention: Control
Control group. Will receive standard prenatal and postnatal care.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01736956
|Contact: Anita Moon-Grady, MD||415-353-1887||Anita.Grady@ucsf.edu|
|United States, California|
|University of California, San Francisco Fetal Treatment Center||Recruiting|
|San Francisco, California, United States, 94143|
|Principal Investigator: Anita Grady, MD|
|Principal Investigator: Hanmin Lee, MD|
|Sub-Investigator: Larry Rand, MD|
|Sub-Investigator: Ruth Goldstein, MD|
|Sub-Investigator: Jeffery Meadows, MD|
|Sub-Investigator: Phillip Moore, MD|
|Sub-Investigator: David Teitel, MD|
|Sub-Investigator: Shabnam Peyvandi, MD|
|Principal Investigator:||Anita Moon-Grady, MD||University of California, San Francisco|