Effect of Fetal Aortic Valvuloplasty on Outcomes (FASSprosp)

March 18, 2025 updated by: Mats Mellander, Queen Silvia Children's Hospital, Gothenburg, Sweden

Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort

In one of the most severe congenital heart defects, hypoplastic left heart syndrome (HLHS), the left ventricle is underdeveloped and the prognosis is worse than in most other heart defects. The underdevelopment can occur gradually during fetal growth caused by a narrowing of the aortic valve. At some international centers, such fetuses are treated with a balloon dilation of the narrowed valve, but there is no scientifically sound evidence that this treatment is effective.

The aim of this study is: 1/ to evaluate whether balloon dilation during the fetal period of a narrowed aortic valve can reduce the risk of the left ventricle becoming underdeveloped and the baby being born with a so-called univentricular heart (HLHS); 2/ to investigate whether such treatment improves the prognosis for this group of children with a very complex and severe heart defect and 3/ to also describe side effects and risks in fetuses and mothers of the fetal procedure.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Routinely collected pre- and postnatal clinical data will be entered into a digital database and echocardiographic examinations will be uploaded to a server. A core lab will measure and analyze all echocardiographic examinations according to protocol. The growth of the left heart structures and the postnatal outcome will be compared between the intervention and non-intervention groups.

The decision whether a fetal balloon dilatation shall be attempted is not part of the study protocol. The number of examinations of mother/fetus/infant in this study is not different from the number of examinations that will be recommended for someone choosing not to be part of this study. Participation in the study does not affect the care and treatment mothers and fetuses are receiving during pregnancy, nor how the infant is examined and treated after birth.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Austria
      • Linz, Austria
  • Canada
      • Toronto, Canada
        • Recruiting
        • The Hospital For Sick Children Toronto
        • Contact:
          • Edgar Jaeggi, Prof
        • Contact:
          • edgar.jaeggi@sickkids.ca
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Department of Paediatric Cardiology, Helsinki University Children's Hospital
        • Contact:
  • Germany
      • Bonn, Germany
        • Recruiting
        • Pediatric Cardiology - University Hospital Bonn
        • Contact:
      • Heidelberg, Germany
      • Munich, Germany
        • Recruiting
        • University hospital Technical university, mother- and-child center
        • Contact:
  • Poland
      • Warsaw, Poland
        • Recruiting
        • Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
        • Contact:
  • Spain
      • Madrid, Spain
        • Recruiting
        • Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
        • Contact:
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Department of Pediatric Cardiology, Skane University Hospital
        • Contact:
      • Stockholm, Sweden
      • Umeå, Sweden
        • Recruiting
        • Department of Pediatrics, Umeå University Hospital
        • Contact:
  • United States
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • Fetal Cardiovascular Program, University of California San Francisco
        • Contact:
    • Ohio

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

5 months to 7 months (Child)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

The study population consists of fetuses and children with aortic valve stenosis and/or hypoplastic left heart syndrome

Description

Inclusion Criteria:

A. All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):

  1. Aortic valve stenosis with antegrade flow through the valve
  2. Predominantly left-to-right shunt at the atrial level
  3. Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
  4. Qualitatively depressed left ventricular function
  5. Left ventricular end-diastolic diameter Z-score > ±0

  6. Left ventricular inlet length in diastole :

    1. Gestational age ≤ 24+6: Z-score > ±0
    2. Gestational age 25+0 to 27+6: Z-score > -0.75
    3. Gestational age ≥ 28+0: Z-score > -1.50
  7. Mitral valve diameter in diastole Z-score > -2.0

B. All of the following postnatal treatment options need to be available: 1. Surgical or catheter based aortic valvotomy 2. Ross-Konno surgery 3. Norwood or hybrid stage-one surgery

Exclusion Criteria:

  1. Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
  2. Any significant (i.e. that might influence outcome) extracardiac anomaly and/or known chromosomal aberration. Also, if such a condition is present at inclusion but diagnosed only after birth the case will be retrospectively excluded.

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fetal intervention group
Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria
Procedure: Fetal aortic balloon dilatation
Fetal valvuloplasty will be performed as described in Arzt W, Wertaschnigg D, Veit I, Klement F, Gitter R, Tulzer G. Intrauterine aortic valvuloplasty in fetuses with critical aortic stenosis: experience and results of 24 procedures. Ultrasound Obstet Gynecol. 2011;37:689-695. with minor variations between centers involved. Technical success is defined as improved forward flow and/or new aortic regurgitation.
Fetal non-intervention group
Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria which are identical with the criteria in the Fetal intervention group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Transplantation-free survival
Time Frame: Follow-up from study inclusion during fetal life until 2 years postnatal age
Transplantation-free survival from fetal diagnosis to 2 years postnatal age with a biventricular circulation without pulmonary hypertension at that time. Absence of pulmonary hypertension is defined as a TR max velocity ≤ 2.8 m/s with no other echocardiographic signs of pulmonary hypertension and/or catheter data showing a mean pulmonary arterial pressure <25 mmHg.
Follow-up from study inclusion during fetal life until 2 years postnatal age

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intervention-related fetal death
Time Frame: From the time of fetal intervention until 24 hours after the intervention
Intervention-related fetal death (defined as fetal death within 24 hours of procedure)
From the time of fetal intervention until 24 hours after the intervention
Fetal death not directly related to the intervention
Time Frame: From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.
Fetal death not directly related to the intervention, except termination of pregnancy
From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.
Maternal complications to fetal intervention procedure
Time Frame: From time of fetal intervention until 24 hours after the intervention
Maternal complications to procedure requiring intensive care or resulting in maternal death
From time of fetal intervention until 24 hours after the intervention
Preterm delivery
Time Frame: From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks
Preterm delivery before 37 weeks gestational age
From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks
Fetal left heart growth
Time Frame: From the date of study inclusion until just before the first postnatal catheter or surgical intervention, or death, whichever comes first, total time frame 7 months
Fetal left heart growth as measured with dimensions expressed a z-scores of the mitral valve diameter, left ventricular inlet length and aortic valve diameter
From the date of study inclusion until just before the first postnatal catheter or surgical intervention, or death, whichever comes first, total time frame 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Queen Silvia Children's Hospital, Gothenburg, Sweden

Collaborators

Swedish Heart Lung Foundation
Sahlgrenska University Hospital

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 (Actual)

January 1, 2021

Primary Completion (Estimated)

December 31, 2029

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

May 13, 2022

First Submitted That Met QC Criteria

May 18, 2022

First Posted (Actual)

May 23, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FASSprosp

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

No

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.

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