The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that examines the efficacy and safety of standard prenatal antiarrhythmic treatment. Study components of FAST include three prospective sub-studies to determine the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF without hydrops (Randomized Clinical Trial (RCT) A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy, which either is started as monotherapy (no hydrops) or as dual therapy (hydrops).
Who can participate
Age range16 Years – 50 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Mother has provided written informed consent to participate
✓. Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops
✓. Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
✓. Gestational age \> 12 0/7 weeks and \<36 0/7 weeks at time of enrollment
✓. Untreated tachycardia at time of enrollment
✓. Singleton Pregnancy
✓. Healthy mother with ± normal pre-treatment cardiovascular findings:
Exclusion criteria
✕. AF with hydrops (eligible for FAST Registry only)
✕. Any maternal-fetal conditions associated with high odds of premature delivery or death other than tachycardia (e.g. severe IUGR; premature rupture of membrane; life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severe congenital fetal abnormalities (T 13 or 18; surgery or death expected \< 1 month)
What they're measuring
1
Proportion of live-born children with a delivery at term and a normal cardiac rhythm