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Fetal Aortic Valvuloplasty for Aortic Stenosis

N/A
Waitlist Available
Led By Anita Moon-Grady, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Dysplastic/stenotic aortic valve with forward flow, with or without gradient, and no significant insufficiency
Left to right atrial shunting
Timeline
Screening 3 weeks
Treatment Varies
Follow Up monthly until birth, and after birth until three years of age
Awards & highlights

Study Summary

This trial found that for fetuses with severe aortic stenosis, in utero balloon aortic valvuloplasty may improve fetal growth of left heart structures.

Eligible Conditions
  • Aortic Stenosis
  • Hypoplastic Left Heart Syndrome

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~birth to 30 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and birth to 30 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Improved fetal mitral valve and left ventricular growth
Secondary outcome measures
Neonatal survival at 365 days of life
Other outcome measures
Neurodevelopmental and functional status

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Fetal Aortic ValvuloplastyExperimental Treatment1 Intervention
Subjects will undergo fetal aortic valvuloplasty
Group II: ControlActive Control1 Intervention
Control group. Will receive standard prenatal and postnatal care.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fetal Aortic Valvuloplasty
2012
N/A
~10

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,493 Previous Clinical Trials
11,931,787 Total Patients Enrolled
Anita Moon-Grady, MDPrincipal InvestigatorUniversity of California, San Francisco

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
~1 spots leftby Mar 2025