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Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

NCT03376438 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 330

Last updated 2025-05-31

No results posted yet for this study

Summary

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

Interventions

OTHER

Prospective observational cohorts

Patients with AF or SVT that is significant enough to consider prenatal treatment are eligible for enrollment. Management decisions are made at each patient encounter by the primary physician based on clinical findings and may include: 1) no antiarrhythmic treatment; 2) transplacental antiarrhythmic treatment; 3) direct fetal antiarrhythmic treatment; 4) delivery. Patients enrolled in the FAST Registry will be followed from the time of enrollment until the baby is discharged after birth.

Sponsors & Collaborators

  • Edgar Jaeggi

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
16 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-08
Primary Completion
2025-03-31
Completion
2025-03-31

Countries

  • United States
  • Australia
  • Brazil
  • Canada
  • Czechia
  • Finland
  • France
  • Hong Kong
  • Netherlands
  • Russia
  • Spain
  • Sweden
  • Switzerland
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03376438 on ClinicalTrials.gov