Effect of Fetal Aortic Valvuloplasty on Outcomes

RecruitingOBSERVATIONAL
Enrollment

200

Participants

Timeline

Start Date

January 1, 2021

Primary Completion Date

December 31, 2029

Study Completion Date

December 31, 2029

Conditions
Congenital Heart DiseaseAortic Valve StenosisFetal Cardiac DisorderHypoplastic Left Heart Syndrome
Interventions
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.

Trial Locations (13)

43205

RECRUITING

Congenital Heart Collaborative, Nationwide Children's Hospital, Columbus

94158

RECRUITING

Fetal Cardiovascular Program, University of California San Francisco, San Francisco

Unknown

RECRUITING

Kinderherzzentrum Linz, Linz

RECRUITING

The Hospital for Sick Children Toronto, Toronto

RECRUITING

Department of Paediatric Cardiology, Helsinki University Children's Hospital, Helsinki

RECRUITING

Pediatric Cardiology - University Hospital Bonn, Bonn

RECRUITING

Department of Pediatric and Congenital Cardiology, University of Heidelberg, Heidelberg

RECRUITING

University hospital Technical university, mother- and-child center, Munich

RECRUITING

Department of Perinatal Cardiology and Congenital Anomalies, Centre of Postgraduate Medical Education., Warsaw

RECRUITING

Fetal Medicine Unit, Dept. Obstetrics & Gynecology University Hospital 12 de Octubre, Madrid

RECRUITING

Department of Pediatric Cardiology, Skane University Hospital, Lund

RECRUITING

Department of pediatric cardiology, Karolinska Institute, Stockholm

RECRUITING

Department of Pediatrics, Umeå University Hospital, Umeå

All Listed Sponsors
collaborator

Swedish Heart Lung Foundation

OTHER

collaborator

Sahlgrenska University Hospital

OTHER

lead

Queen Silvia Children's Hospital, Gothenburg, Sweden

OTHER