Congenital Heart DiseaseFASSprospNCT05386173
Effect of Fetal Aortic Valvuloplasty on Outcomes
An observational study of Congenital Heart Disease and Aortic Valve Stenosis, run by Queen Silvia Children's Hospital, Gothenburg, Sweden at 13 sites in 8 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 23 to 31 weeks
- Conditions the study is for
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder
- What is being tested?
- Fetal aortic balloon dilatation
- Type of treatment
- Surgery or procedure
- How many people
- 200 participants
- Where
- 13 sitesin 8 countries
- Study dates
- 1 Jan 2021to 31 Dec 2029
- How long will I take part?
- 3 Years
- Phase
- Observational
- 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 23 to 31 weeks
- All sexes
- No healthy volunteers
- Child
Study population: The study population consists of fetuses and children with aortic valve stenosis and/or hypoplastic left heart syndrome
Who may be able to join
- All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
- Aortic valve stenosis with antegrade flow through the valve
- Predominantly left-to-right shunt at the atrial level
- Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
- Qualitatively depressed left ventricular function
- Left ventricular end-diastolic diameter Z-score > ±0
Show all 12Show fewer
- Left ventricular inlet length in diastole :
- Gestational age ≤ 24+6: Z-score > ±0
- Gestational age 25+0 to 27+6: Z-score > -0.75
- Gestational age ≥ 28+0: Z-score > -1.50
- Mitral valve diameter in diastole Z-score > -2.0
- 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
Who cannot join
- Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
- 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.
Trial locations and contacts
13 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
13 sites in 8 countries
Germany3 sites, 3 recruiting
- Recruiting
Pediatric Cardiology - University Hospital Bonn
Bonn
Ulrike Herberg, Prof, Ulrike.Herberg@ukbonn.de
- Recruiting
Department of Pediatric and Congenital Cardiology, University of Heidelberg
Heidelberg
Alexander Kovacevic, Dr, Alexander.Kovacevic@med.uni-heidelberg.de
- Recruiting
University hospital Technical university, mother- and-child center
Munich
Renate Oberhoffer, Prof, renate.oberhoffer@tum.de
Sweden3 sites, 3 recruiting
- Recruiting
Department of Pediatric Cardiology, Skane University Hospital
Lund
Petru Liuba, petru.liuba@med.lu.se
- Recruiting
Department of pediatric cardiology, Karolinska Institute
Stockholm
Gunnar Bergman, Ggunnar.e.bergman@regionstockholm.se
- Recruiting
Department of Pediatrics, Umeå University Hospital
Umeå
Annika Rydberg, annika.rydberg@umu.se
United States2 sites, 2 recruiting
- Recruiting
Congenital Heart Collaborative, Nationwide Children's Hospital
Columbus, Ohio, 43205
Aimee Armstrong, Prof, ArmstrAimee.Armstrong@nationwidechildrens.org
- Recruiting
Fetal Cardiovascular Program, University of California San Francisco
San Francisco, California, 94158
Anita Grady, Prof, Anita.Grady@ucsf.edu
Austria1 site, 1 recruiting
- Recruiting
Kinderherzzentrum Linz
Linz
Andreas Tulzer, Dr, andreastulzer@gmx.at
Canada1 site, 1 recruiting
- Recruiting
The Hospital for Sick Children Toronto
Toronto
Edgar Jaeggi, Prof
edgar.jaeggi@sickkids.ca
Finland1 site, 1 recruiting
- Recruiting
Department of Paediatric Cardiology, Helsinki University Children's Hospital
Helsinki
Olli Pitkänen, Prof, Olli.Pitkanen@hus.fi
Poland1 site, 1 recruiting
- Recruiting
Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education.
Warsaw
Agnieszka Grzyb, Dr, agagrzyb@gmail.com
Spain1 site, 1 recruiting
- Recruiting
Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre
Madrid
Alberto Galindo, Prof, agalindo@salud.madrid.org
About this study
Official title: 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.
Read the 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.
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Being tested
- Fetal aortic balloon dilatation
- Medical subject headings
- Heart Defects, Congenital, Aortic Valve Stenosis, 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 balloon dilatationProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Fetal intervention group | Fetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria Receives: Procedure: Fetal aortic balloon dilatation | |
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Transplantation-free survival
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.
Measured: Follow-up from study inclusion during fetal life until 2 years postnatal age
Secondary outcomes (5)
Intervention-related fetal death
Intervention-related fetal death (defined as fetal death within 24 hours of procedure)
Measured: From the time of fetal intervention until 24 hours after the intervention
Fetal death not directly related to the intervention
Fetal death not directly related to the intervention, except termination of pregnancy
Measured: From 24 hours after fetal intervention until fetal death, up to 20 weeks after study inclusion.
Maternal complications to fetal intervention procedure
Maternal complications to procedure requiring intensive care or resulting in maternal death
Measured: From time of fetal intervention until 24 hours after the intervention
Preterm delivery
Preterm delivery before 37 weeks gestational age
Measured: From time of fetal intervention until 37 weeks gestational age, maximum 14 weeks
Fetal left heart growth
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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start1 Jan 2021
- Primary completion31 Dec 2029 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Queen Silvia Children's Hospital, Gothenburg, Sweden
- Sponsor type
- University, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Mats Mellander, Queen Silvia Children's Hospital, Gothenburg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386173
- Sponsor's protocol ID
- FASSprosp
- Acronym
- FASSprosp
- Status last verified
- Mar 2025
- First submitted
- 13 May 2022
- Last updated
- 21 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Fetal Aortic Valvuloplasty on Outcomes. A Prospective Observational Cohort Study With a Comparison Cohort
- ClinicalTrials.gov ID
- NCT05386173
- Acronym / sponsor ID
- FASSprosp / FASSprosp
- Conditions
- Congenital Heart Disease, Aortic Valve Stenosis, Fetal Cardiac Disorder, Hypoplastic Left Heart Syndrome
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Queen Silvia Children's Hospital, Gothenburg, SwedenUniversity, hospital or other
- Collaborators
- Swedish Heart Lung Foundation, Sahlgrenska University Hospital
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 23 May 2022 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fetal intervention group | – | Procedure: Fetal aortic balloon dilatationFetuses with aortic valve stenosis satisfying all of the inclusion/exclusion criteria |
| 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 |
Who may qualify
- Ages
- 23 to 31 weeks
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- The study population consists of fetuses and children with aortic valve stenosis and/or hypoplastic left heart syndrome
Key inclusion criteria (12 listed)
- All of the following echocardiographic criteria need to be satisfied between 23+0 and 31+6 weeks (z-scores according to Schneider et al):
- Aortic valve stenosis with antegrade flow through the valve
- Predominantly left-to-right shunt at the atrial level
- Predominantly retrograde flow in the aortic arch between the first two brachiocephalic vessels
- Qualitatively depressed left ventricular function
Key exclusion criteria (2 listed)
- Any associated cardiac defect except persistent left superior vena cava and coarctation of the aorta
- 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.
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 balloon dilatationFetal 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. | Procedure or surgery | Fetal intervention group |
Primary outcome
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.
5 secondary outcomes
Intervention-related fetal death
Time frame: 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.
Maternal complications to fetal intervention procedure
Time frame: 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
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
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 21 Mar 2025.
- 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.
13 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease and Aortic Valve Stenosis, run by Queen Silvia Children's Hospital, Gothenburg, Sweden at 13 sites in 8 countries.
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 12 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 21 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 13 sites in Germany, Sweden, United States, Austria, Canada and 3 more countries. 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?
Contact Mats Mellander, Dr, Prof (0046705530606, mats.mellander@vgregion.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Transplantation-free survival (time frame: Follow-up from study inclusion during fetal life until 2 years postnatal age). 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 21 Mar 2025.