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Fetal Intervention for Aortic Stenosis and Evolving Hypoplastic Left Heart Syndrome

NCT01736956 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2023-01-09

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Anita Moon-Grady, MD · University of California, San Francisco

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2022-10-31
Completion
2022-10-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01736956 on ClinicalTrials.gov