Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Part of paid clinical trials in Rochester, Minnesota.

Sponsor
Mauro H. Schenone
Study ID
NCT06342999
Status
Enrolling By Invitation

Conditions

  • Hypoplastic Left Heart Syndrome

Eligibility Criteria

Sex
FEMALE
Age
N/A - 45 Years
Healthy Volunteers
Accepted

Interventions

  • Fetal Aortic Valvuloplasty Procedure — PROCEDURE
    Treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve in vitro.
  • Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter — DEVICE
    Balloon Catheter
  • Trek RX and Mini Trek RX Coronary Dilatation Catheter — DEVICE
    Coronary Dilation Catheter

Study Details

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

Key Dates

Start date
Jan 1, 2027
Status verified
Apr 2026
Primary completion
Jul 31, 2036
Completion
Jul 31, 2036

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Intervention Group: Fetal Aortic Valvuloplasty
    Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation.
  • No Intervention: Control Group: Expectant Management
    Women diagnosed with HLHS will undergo expectant management with postnatal surgery.

Primary Outcome Measure

Number of cases in which the procedure was successful [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Mayo Clinic in RochesterRochesterMinnesota55905-

Find similar trials in Rochester, MN

By research site
Mayo Clinic in Rochester· Rochester, MN

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