Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Completed

Conditions studied: Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Atrial Ectopic, Tachycardia, Reciprocating, Tachycardia Atrial, Tachycardia, Atrioventricular Nodal Reentry, Tachycardia, Paroxysmal, Fetal Hydrops

In brief

The FAST Trial Registry is a prospective observational cohort study of fetuses with a new diagnosis of atrial flutter (AF) or supraventricular tachycardia (SVT) that is severe enough to consider prenatal treatment (see eligibility criteria below). Aims of the Registry include to establish a large clinical database to determine and compare the efficacy and safety of different prenatal treatment strategies including observation without immediate treatment, transplacental antiarrhythmic fetal treatment and direct fetal treatment from the time of tachycardia diagnosis to death, neonatal hospital discharge or to a maximum of 30 days after birth.

Key facts

Study ID

NCT03376438

Run by

Edgar Jaeggi

People needed

330

Starts

2017-06-08

Expected to finish

2025-03-31

Last updated by the study team

2025-05-31

Who can join

Age: 16 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Mother has provided written informed consent to participate
• Fetal AF or SVT with or without hydrops
• Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
• Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer
• Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)
• Tachycardia ≥ 280 bpm (irrespective of SVA duration)
• SVT with fetal hydrops (irrespective of duration)
• Gestational age <36 0/7 weeks at time of enrollment
• Singleton Pregnancy
• Healthy mother with ± normal pre-treatment cardiovascular findings:
• ECG within normal range (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec; QRS: ≤ 0.12 sec; insignificant anomalies; isolated premature beats; isolated complete right bundle
• Maternal resting heart rate ≥ 50 bpm
• Maternal systolic BP ≥ 85 mmHg

You may not qualify if…

• Primary delivery for postnatal cardioversion
• Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
• Any maternal-fetal conditions associated with high odds of premature delivery and/or death
• History of significant maternal heart condition (open heart surgery; sick sinus syndrome; long QT, Brugada syndrome; ventricular tachycardia; WPW syndrome; high-degree heart block; cardiomyopathy)

Where it is running

• Phoenix Children's Hospital — Phoenix, Arizona, United States
• University of California, San Francisco — San Francisco, California, United States
• Children's Hospital Colorado — Denver, Colorado, United States
• Children's National Medical Center — Washington D.C., District of Columbia, United States
• Johns Hopkins All Children's Hospital — Saint Petersberg, Florida, United States
• John Ochsner Heart & Vascular Institute — New Orleans, Louisiana, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• Children's Health Care — Minneota, Minnesota, United States
• Children's Mercy Kansas City — Kansas City, Missouri, United States
• Cohen Children's Medical Centre/Northwell Health - Lake Success — Lake Success, New York, United States
• Columbia University — New York, New York, United States
• Cincinnati Children's Hospital Medical Centre — Cincinnati, Ohio, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Inc Pediatric Cardiology of Austin Practice — Austin, Texas, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Utah — Salt Lake City, Utah, United States
• West Virginia University Research Corporation — Morgantown, West Virginia, United States
• Children's Hospital of Wisconsin — Milwaukee, Wisconsin, United States
• The Royal Women's Hospital — Melbourne, Australia
• Associação Beneficente Síria - Hospital do Coração — São Paulo, Brazil
• University of Alberta — Edmonton, Alberta, Canada
• The U of British Columbia — Vancouver, British Columbia, Canada
• Alberta Children's Hospital — Calgary, Ontario, Canada
• London Health Sciences Centre — London, Ontario, Canada
• The Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.