Michael A Belfort
The goal of this clinical trial is to evaluate the feasibility and safety of fetal embolization for severe, otherwise lethal, Vein of Galen Malformation (VOGM) via a laparotomy-assisted approach by assessing maternal, fetal, neonatal, and infant outcomes in a cohort of 10 participants. The hypothesis is that in utero embolization of severe VOGM will reduce postnatal mortality and morbidity in severe VOGM infants with minimal maternal risks and acceptably low fetal risks.
Participants will be offered the FETTUS technique as an alternative to the traditional standard postnatal VOGM embolization if all study criteria are met. During the surgery, the mother's uterus is exteriorized using the standard laparotomy approach that we currently use for our fetoscopic spina bifida repair and then transuterine fetal cardiac access is obtained under continuous ultrasound guidance. Once the needle is in place, a microcatheter is advanced through the blood vessels in the heart and up to the site of the malformation in the brain. The malformation will be embolized using medica…
Inclusion Criteria: 1. Pregnant woman - maternal age 18 years or older 2. Singleton pregnancy 3. Prenatal sonographic evidence of Vein of Galen Malformation (VOGM) between 23-0/7 and 37-0/7 weeks of gestation 4. VOGM volume ratio (VBR) \>9.69% and narrowest mediolateral diameter of the straight or falcine sinus (\>10.15 mm) on prenatal magnetic resonance imaging (MRI) 5. Worsening VOGM severity on follow up prenatal imaging (i.e. ultrasound, MRI and/or echocardiography), and exceeding the specified threshold measurements in any one or more of the following prognostic markers: VOGM varix volum…
Participants will undergo a laparotomy, exteriorization of the uterus, and uterine needle puncture to obtain fetal cardiac access so a catheter can be inserted into an artery and guided up to the site of the malformation. A liquid embolic system (Trufill n-Butyl CyanoAcrylate, Johnson \& Johnson) will be used to occlude the dominant arterial pedicle supplying the shunt.
Arctuva estimate
Actual pay is set by the research site.
Verify or correct the compensation shown for this listing.