Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

NCT06342999 | Enrolling By Invitation DMC FDA Device

• 1 other identifier: 22-012399
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Hypoplastic Left Heart Syndrome

Outcome Measures

Primary Outcomes (3)

• Number of cases in which the procedure was successful

  Procedure success defined as the aortic valve was crossed and the balloon inflated with clear evidence of improvement of blood flow through the aortic valve and or new aortic valve regurgitation

  Baseline

• Number of cases in which a biventricular repair was achieved

  Baseline

• Number cases with pulmonary hypertension

  Baseline

Secondary Outcomes (3)

• Number of cases delivered prematurely

  Baseline

• Number of cases with perinatal death

  Baseline

• Number of maternal complications

  Baseline

Study Arms (2)

Intervention Group: Fetal Aortic Valvuloplasty

EXPERIMENTAL

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

Procedure: Fetal Aortic Valvuloplasty Procedure; Device: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter; Device: Trek RX and Mini Trek RX Coronary Dilatation Catheter

Control Group: Expectant Management

NO INTERVENTION

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

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.

Intervention Group: Fetal Aortic Valvuloplasty

Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter DEVICE

Balloon Catheter

Intervention Group: Fetal Aortic Valvuloplasty

Trek RX and Mini Trek RX Coronary Dilatation Catheter DEVICE

Coronary Dilation Catheter

Intervention Group: Fetal Aortic Valvuloplasty

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women 18-45 years of age.
• Gestational age between 21 0/7 and 29 6/7 weeks of gestation
• The mother must be healthy enough to undergo surgery.
• The individual being enrolled must be able to provide informed consent.
• Dominant cardiac defect is valvar
• Evolving hypoplastic left heart syndrome defined as depressed left ventricle systolic and at least one of the following:
• Retrograde flow in the transverse aortic arch
• Two of the following: (1) left to right flow across the atrial septum (bulging of the septum left to right in cases of intact atrial septum); (2) monophasic mitral valve inflow; (3) bidirectional flow in the pulmonary veins.
• Potential for a technically successful and postnatal biventricular outcome defined as left ventricle long axis Z-score equal or greater than -2 PLUS at least 4 of the following 5 criteria:
• Left ventricle long axis Z-score more than zero
• Left ventricle short axis Z-score more than zero
• Aortic annulus Z-score more than -3.5
• Mitral valve annulus Z-score more than -2
• Left ventricle generating a maximal instantaneous gradient (MIG) equal or greater than 20 mmHg (or by mitral regurgitation jet greater than or equal to 20 mmHg).

You may not qualify if:

• Patient is less than 18 years of age or more than 45 years of age.
• Contraindication to anesthesia or surgery
• Preterm labor or cervical length \<20 mm at enrollment or uterine anomaly strongly predisposing to preterm delivery.
• Other fetal anomalies that significantly impact fetal/neonatal survival (e.g., congenital diaphragmatic hernia, bilateral renal agenesis, etc.)
• Fetal aneuploidy and pathogenic findings on Karyotype or Microarray that impact significantly the fetal/neonatal survival.
• Cases with all the following criteria:
• Left ventricle pressure ≤ 47 mmHg
• MV dimension Z-score \< 0.1
• MV inflow time Z-score \< -2

Sponsors & Collaborators

• Mauro H. Schenone: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Hypoplastic Left Heart Syndrome

Condition Hierarchy (Ancestors)

Heart Defects, Congenital; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Mauro Schenone, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Regulatory Sponsor and Principal Investigator

Study Record Dates

• First Submitted: March 27, 2024
• First Posted: April 2, 2024
• Study Start (Estimated): January 1, 2027
• Primary Completion (Estimated): July 1, 2036
• Study Completion (Estimated): July 1, 2036
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)