Fetal Aortic Valvuloplasty for Hypoplastic Left Heart Syndrome

Recruiting in Palo Alto (17 mi)

Mauro H. Schenone, M.D. - Doctors and ...

Overseen byMauro Schenone, MD

Age: < 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Mauro H. Schenone

No Placebo Group

Trial Summary

What is the purpose of this trial?

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

Research Team

Mauro Schenone, MD

Principal Investigator

Mayo Clinic

Eligibility Criteria

This trial is for pregnant women aged 18-45 with a fetus diagnosed with evolving hypoplastic left heart syndrome (HLHS). The mother must be healthy for surgery, between 21 and almost 30 weeks pregnant. Criteria include specific measurements of the fetal heart's structure and function indicating potential for successful treatment.

Inclusion Criteria

I am healthy enough for surgery.

Gestational age between 21 0/7 and 29 6/7 weeks of gestation

My main heart issue is related to the heart valves.

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Exclusion Criteria

Cases with all the following criteria: Left ventricle pressure ≤ 47 mmHg, MV dimension Z-score < 0.1, MV inflow time Z-score < -2

I cannot have surgery or anesthesia due to health risks.

I am either younger than 18 or older than 45.

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Treatment Details

Interventions

Fetal Aortic Valvuloplasty (Procedure)

Trial OverviewThe study tests fetal aortic valvuloplasty using specialized catheters like Emerge Monorail, Over-The-Wire PTCA Dilatation Catheter, Trek RX, and Mini Trek RX to manage HLHS in fetuses. It aims to find out if this can improve outcomes by promoting normal left heart development.

Participant Groups

2Treatment groups

Experimental Treatment

Active Control

Group I: Intervention Group: Fetal Aortic ValvuloplastyExperimental Treatment3 Interventions

Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation.

Group II: Control Group: Expectant ManagementActive Control1 Intervention

Women diagnosed with HLHS will undergo expectant management with postnatal surgery.