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Pioneering fetal brain surgery aims to prevent newborn heart failure

NCT ID NCT04434729

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a one-time procedure to treat a rare brain blood vessel problem called Vein of Galen malformation while the baby is still in the womb. Doctors use a needle through the mother's abdomen and the fetal skull to place tiny coils that block the abnormal blood flow. The goal is to prevent severe complications after birth, such as heart failure and brain damage. The trial includes 7 fetuses and compares results to past cases without this treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
detachable platinum coils (Target XL and XXL Detachable Coil, Stryker Neurovascular)
What this could lead to
If successful, this could offer a way to treat a severe brain blood vessel condition before birth, potentially preventing heart failure and brain damage in newborns.
What could go wrong
This is a very early, small study with only 7 participants and no control group. The procedure carries risks for both fetus and mother, including bleeding, preterm delivery, or fetal death.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

7 people

The number who actually took part.

Started

Sep 2022

Expected to finish

Aug 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Pregnant woman carrying a fetus harboring a vein of Galen malformation in whom the straight sinus or falcine sinus draining the prosencephalic varix measures 7 mm or more on fetal MRI (medio-lateral diameter measured at the narrowest point of the sinus along the rostral-caudal axis, assessed on a T2-weighted coronal slice). * Fetal gestational age between 23 weeks and term as determined by clinical information and evaluation of first ultrasound. * Anatomic diagnosis of fetal vein of Galen malformation. * Well preserved brain parenchyma. * Maternal age of 18 years and older. * Eligible for continuous lumbar epidural anesthesia. * Able to travel to study site for study evaluation, procedures and visits. Exclusion Criteria: * Extensive fetal brain parenchymal injury/gliosis, \>10% of supratentorial brain volume (i.e., SFP presentation). This is a degree of fetal brain injury beyond which the risk of significant neurological morbidity is high, based on studies of prenatal ischemic stroke. * Irreversible fetal non-brain organ injury (e.g. hydrops fetalis as a manifestation of heart failure, a finding which portends fatal outcome in fetuses with vein of Galen malformation), i.e., SFP presentation. * Fetus with VOGM in whom the straight sinus or falcine sinus draining the prosencephalic varix measures less than 7 mm on fetal MRI (T2-weighted coronal slice, medio-lateral diameter measured at the narrowest point of the sinus along the anterior-posterior axis), fitting fetal MRI criteria for likely evolution into the IT cohort. * Severe maternal obesity pre-pregnancy as defined by body mass index (BMI) of 40 or greater. * Fetuses with major congenital anomalies. * Evidence of preterm labor, rupture of membranes or abruption. * Maternal coagulopathy: INR \> 1.2; PT/PTT above normal ranges for the lab; platelets \<100. * Medical disease requiring current anticoagulation including maternal deep vein thrombosis. * Prior maternal medical history that would preclude epidural anesthesia. * Multi-fetal pregnancy. * Placenta previa or accreta. * Participation in another fetal study that influences maternal and fetal morbidity and mortality. * Known maternal hypersensitivity to 316LM stainless steel. * Supine hypotensive syndrome.

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Conditions

The condition(s) this trial relates to.

vein of Galen aneurysm Vein of Galen Malformations

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.