Fetal Aortic Valvuloplasty for Evolving Hypoplastic Left Heart Syndrome

Overview

About this study

The purpose of this study is to evaluate the outcomes of fetal aortic valvuloplasty performed in cases selected using a refined inclusion criteria (use the 2009 criteria) and exclude group/category (Friedman et al. 20182 – see section 3.3).  Left ventricle pressure ≤ 47 mmHg, MV dimension Z-score < 0.1 and MV inflow time Z-score < -2). Our hypothesis is that utilizing a refined selection criteria the outcomes can be further improved.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 8/12/2024. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Mauro Schenone, M.D.

Contact us for the latest status

Contact information:

Hannah Scott

(507) 293-2542

Scott.Hannah3@mayo.edu

More information

Publications

Publications are currently not available