Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Description

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.

Conditions

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

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Study Overview

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Study Details

Study overview

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.

FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Condition
Atrial Flutter
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Children's Hospital, Phoenix, Arizona, United States, 85016

San Francisco

University of California, San Francisco, San Francisco, California, United States, 94158

Denver

Children's Hospital Colorado, Denver, Colorado, United States, 80205

Washington

Children's National Medical Center, Washington, District of Columbia, United States, 20010

Saint Petersburg

Johns Hopkins All Children's Hospital, Saint Petersburg, Florida, United States, 33701-4804

New Orleans

John Ochsner Heart & Vascular Institute, New Orleans, Louisiana, United States, 70121

New Orleans

John Ochsner Heart & Vascular Institute, New Orleans, Louisiana, United States, 70121

Boston

Boston Children's Hospital, Boston, Massachusetts, United States, 02115

Minnesota

Children's Health Care, Minnesota, Minnesota, United States, 55404

Kansas City

Children's Mercy Kansas City, Kansas City, Missouri, United States, 64108

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. Mother has provided written informed consent to participate
  • 2. Fetal AF or SVT with or without hydrops
  • 3. 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)
  • 4. Gestational age \<36 0/7 weeks at time of enrollment
  • 5. Singleton Pregnancy
  • 6. 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
  • 1. Primary delivery for postnatal cardioversion
  • 2. Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
  • 3. Any maternal-fetal conditions associated with high odds of premature delivery and/or death
  • 4. 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)

Ages Eligible for Study

16 Years to 50 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Edgar Jaeggi,

Edgar Jaeggi, MD, FRCPC, PRINCIPAL_INVESTIGATOR, The Hospital for Sick Children, Toronto, ON, Canada

Study Record Dates

2025-05-31