Hypoplastic Left Heart SyndromeNCT06342999
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
A study testing Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter and Trek RX and Mini Trek RX Coronary Dilatation Catheter in people with Hypoplastic Left Heart Syndrome, run by Mauro H. Schenone at 1 site in United States.
Trial summary
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS). Read more about this study
- Who is it for?
- Ages Up to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypoplastic Left Heart Syndrome
- What is being tested?
- Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter and Trek RX and Mini Trek RX Coronary Dilatation Catheter
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2027to Jul 2036
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 45 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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:
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- 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).
Who cannot join
- 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:
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- Left ventricle pressure ≤ 47 mmHg
- MV dimension Z-score < 0.1
- MV inflow time Z-score < -2
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Evaluation of Outcomes of Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).
Read the detailed description
The condition occurs when part of the heart doesn't develop properly so the heart is not able to pump blood around the body effectively. Babies born with this condition require surgery and are often left with a lifelong heart disability. A number of babies with this condition will die during pregnancy or within the first year of life (approximately 10-40%). We are investigating a treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve. The aortic valve function is to allow easy flow from the heart to the body and prevent blood from returning to the heart (regurgitation). This is called fetal aortic valvuloplasty. A number of studies have shown promising results, including a higher of the baby surviving with both sides of the heart functioning (as opposed to only the right side), this may also lead to longer survival with a better quality of life. However, we do not have enough information to say this is always the best way to manage the condition. Currently, parents of babies with this condition, who meet certain eligibility criteria, are offered fetal aortic valvuloplasty during pregnancy. The alternative option is not to intervene during pregnancy but instead monitor the baby with regular ultrasounds. We call this conservative management.
- Conditions
- Hypoplastic Left Heart Syndrome
- Being tested
- Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter, Trek RX and Mini Trek RX Coronary Dilatation Catheter
- Medical subject headings
- Hypoplastic Left Heart Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fetal Aortic Valvuloplasty ProcedureProcedure or surgery
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 CatheterDevice
Balloon Catheter
Trek RX and Mini Trek RX Coronary Dilatation CatheterDevice
Coronary Dilation Catheter
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Fetal Aortic Valvuloplasty | Experimental | Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline
Number of cases in which a biventricular repair was achieved
Measured: Baseline
Number cases with pulmonary hypertension
Measured: Baseline
Secondary outcomes (3)
Number of cases delivered prematurely
Measured: Baseline
Number of cases with perinatal death
Measured: Baseline
Number of maternal complications
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2024
- Study start1 Jan 2027 (estimated)
- Primary completionJul 2036 (estimated)
- Study completionJul 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypoplastic Left Heart SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mauro H. Schenone
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mauro H. Schenone, Mayo Clinic
- Investigators
- Mauro Schenone, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06342999
- Sponsor's protocol ID
- 22-012399
- Status last verified
- Apr 2026
- First submitted
- 27 Mar 2024
- Last updated
- 1 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Outcomes of Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
- ClinicalTrials.gov ID
- NCT06342999
- Acronym / sponsor ID
- 22-012399
- Conditions
- Hypoplastic Left Heart Syndrome
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Mauro H. SchenoneUniversity, hospital or other
- Study start
- 1 Jan 2027 (estimated)
- Primary completion
- Jul 2036 (estimated)
- Study completion
- Jul 2036 (estimated)
- First posted
- 2 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to investigate the best way to manage evolving hypoplastic left heart syndrome (HLHS).
Detailed description
The condition occurs when part of the heart doesn't develop properly so the heart is not able to pump blood around the body effectively. Babies born with this condition require surgery and are often left with a lifelong heart disability. A number of babies with this condition will die during pregnancy or within the first year of life (approximately 10-40%). We are investigating a treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve. The aortic valve function is to allow easy flow from the heart to the body and prevent blood from returning to the heart (regurgitation). This is called fetal aortic valvuloplasty. A number of studies have shown promising results, including a higher of the baby surviving with both sides of the heart functioning (as opposed to only the right side), this may also lead to longer survival with a better quality of life. However, we do not have enough information to say this is always the best way to manage the condition. Currently, parents of babies with this condition, who meet certain eligibility criteria, are offered fetal aortic valvuloplasty during pregnancy. The alternative option is not to intervene during pregnancy but instead monitor the baby with regular ultrasounds. We call this conservative management.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Fetal Aortic Valvuloplasty | Experimental | Procedure: Fetal Aortic Valvuloplasty Procedure, Device: Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter, Device: Trek RX and Mini Trek RX Coronary Dilatation CatheterWomen diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation. |
| Control Group: Expectant Management | No intervention | –Women diagnosed with HLHS will undergo expectant management with postnatal surgery. |
Who may qualify
- Ages
- Up to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fetal Aortic Valvuloplasty ProcedureTreatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve in vitro. | Procedure or surgery | Intervention Group: Fetal Aortic Valvuloplasty |
| Emerge Monorail and Over-The-Wire PTCA Dilatation CatheterBalloon Catheter | Device | Intervention Group: Fetal Aortic Valvuloplasty |
| Trek RX and Mini Trek RX Coronary Dilatation CatheterCoronary Dilation Catheter | Device | Intervention Group: Fetal Aortic Valvuloplasty |
Primary outcome
Number of cases in which the procedure was successful
Time frame: Baseline
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
Number of cases in which a biventricular repair was achieved
Time frame: Baseline
Number cases with pulmonary hypertension
Time frame: Baseline
3 secondary outcomes
Number of cases delivered prematurely
Time frame: Baseline
Number of cases with perinatal death
Time frame: Baseline
Number of maternal complications
Time frame: Baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2026.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Mauro Schenone, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fetal Aortic Valvuloplasty Procedure, Emerge Monorail and Over-The-Wire PTCA Dilatation Catheter and Trek RX and Mini Trek RX Coronary Dilatation Catheter in people with Hypoplastic Left Heart Syndrome, run by Mauro H. Schenone at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 1 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of cases in which the procedure was successful (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2026.