Status:
COMPLETED
Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Lead Sponsor:
Edgar Jaeggi
Conditions:
Atrial Flutter
Tachycardia, Supraventricular
Eligibility:
FEMALE
16-50 years
Brief 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 prena...
Detailed Description
Few studies are specifically designed to address health concerns relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
June 8 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 31 2025
Estimated Enrollment :
330 Patients enrolled
Trial Details
Trial ID
NCT03376438
Start Date
June 8 2017
End Date
March 31 2025
Last Update
May 31 2025
Active Locations (41)
Enter a location and click search to find clinical trials sorted by distance.
1
Phoenix Children's Hospital
Phoenix, Arizona, United States, 85016
2
University of California, San Francisco
San Francisco, California, United States, 94158
3
Children's Hospital Colorado
Denver, Colorado, United States, 80205
4
Children's National Medical Center
Washington D.C., District of Columbia, United States, 20010