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Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

NCT06342999 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2026-05-01

No results posted yet for this study

Summary

The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).

Conditions

Interventions

DEVICE

Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter

Balloon Catheter

DEVICE

Trek RX and Mini Trek RX Coronary Dilatation Catheter

Coronary Dilation Catheter

PROCEDURE

Fetal Aortic Valvuloplasty Procedure

Treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve in vitro.

Sponsors & Collaborators

  • Mauro H. Schenone

    lead OTHER

Principal Investigators

  • Mauro Schenone, MD · Mayo Clinic

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2027-01-01
Primary Completion
2036-07-31
Completion
2036-07-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT06342999 on ClinicalTrials.gov