- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06342999
Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome
April 8, 2024 updated by: Mauro H. Schenone
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).
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Interventional
Enrollment (Estimated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria
- 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).
Exclusion Criteria
- 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 enrollement 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intervention Group: Fetal Aortic Valvuloplasty
Women diagnosed with HLHS will undergo fetal aortic valvuloplasty between 21 and 29 weeks gestation.
|
Treatment given during pregnancy in which a balloon is used to increase the size of the baby's aortic valve in vitro.
Balloon Catheter
Coronary Dilation Catheter
|
No Intervention: Control Group: Expectant Management
Women diagnosed with HLHS will undergo expectant management with postnatal surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Baseline
|
Number of cases in which a biventricular repair was achieved
Time Frame: Baseline
|
Baseline
|
|
Number cases with pulmonary hypertension
Time Frame: Baseline
|
Baseline
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of cases delivered prematurely
Time Frame: Baseline
|
Baseline
|
Number of cases with perinatal death
Time Frame: Baseline
|
Baseline
|
Number of maternal complications
Time Frame: Baseline
|
Baseline
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Mauro Schenone, MD, Mayo Clinic
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
July 1, 2024
Primary Completion (Estimated)
July 1, 2035
Study Completion (Estimated)
July 1, 2035
Study Registration Dates
First Submitted
March 27, 2024
First Submitted That Met QC Criteria
March 27, 2024
First Posted (Actual)
April 2, 2024
Study Record Updates
Last Update Posted (Actual)
April 10, 2024
Last Update Submitted That Met QC Criteria
April 8, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 22-012399
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hypoplastic Left Heart Syndrome
-
Mayo ClinicRecruitingHypoplastic Left Heart Syndrome (HLHS)United States
-
Children's Hospital Medical Center, CincinnatiRecruitingHypoplastic Left Heart Syndrome (HLHS)United States, United Kingdom, Canada
-
Emory UniversityCompleted
-
Athena ZuppaCompletedHypoplastic Left Heart | Tetrology of Fallot | Heart VentricleUnited States
-
HealthCore-NERISuspendedCongenital Heart Disease | Hypoplastic Left HeartUnited States, Canada
-
Athena ZuppaCompletedTetralogy of Fallot | Tricuspid Atresia | Hypoplastic Left Heart
-
Nationwide Children's HospitalNational Heart, Lung, and Blood Institute (NHLBI); National Institutes of Health... and other collaboratorsRecruitingHeart Diseases | Cardiovascular Diseases | Heart Defects, Congenital | Cardiovascular Abnormalities | HLH - Hypoplastic Left Heart Syndrome | DORV | DILV - Double Inlet Left Ventricle | Mitral Atresia | Tricuspid Atresia | Unbalanced AV Canal | Single-ventricleUnited States
-
Baylor College of MedicineCompletedCongenital Heart Disease | Cardiac Disease | Hypoplastic Left Heart | Cyanotic Congenital Heart DiseaseUnited States
-
Okayama UniversityTranslational Research Center for Medical Innovation, Kobe, Hyogo, JapanCompletedHypoplastic Left Heart Syndrome | Single Right Ventricle | Single Left VentricleJapan
-
Kevin HillCompletedHypoplastic Left Heart Syndrome | Hypoplastic Right-sided Heart ComplexUnited States
Clinical Trials on Fetal Aortic Valvuloplasty Procedure
-
University of California, San FranciscoCompletedAortic Stenosis | Hypoplastic Left Heart SyndromeUnited States
-
Royal Sussex County HospitalUnknown
-
University Hospital of FerraraCompleted
-
IRCCS Azienda Ospedaliero-Universitaria di BolognaUnknown
-
Opsens, Inc.Recruiting
-
National and Kapodistrian University of AthensCompletedAortic Valve StenosisGreece, Israel
-
InterValve, Inc.CompletedAortic Valve StenosisUnited States
-
Queen Silvia Children's Hospital, Gothenburg, SwedenSahlgrenska University Hospital, Sweden; Swedish Heart Lung FoundationRecruitingAortic Valve Stenosis | Congenital Heart Disease | Hypoplastic Left Heart Syndrome | Fetal Cardiac DisorderUnited States, Austria, Canada, Finland, Germany, Poland, Spain, Sweden
-
Medstar Health Research InstituteTerminatedAortic Valve Stenosis
-
University of California, San FranciscoCompletedNeurocognitive DysfunctionUnited States, Canada