Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Tachycardia, Supraventricular | Atrial Flutter | Fetal Hydrops | Tachycardia, Atrioventricular Nodal...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.
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Participation Requirements
-
Sex:
FEMALE -
Eligible Ages:
16 to 50
Participation Criteria
Inclusion 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
Exclusion Criteria:
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)
Study Location
London Health Sciences Centre
London Health Sciences CentreLondon, Ontario
Canada
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Michael Grattan
Alberta Children's Hospital
Alberta Children's HospitalCalgary, Ontario
Canada
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Deborah Fruitman
CHU Saine-Justine
CHU Saine-JustineMontréal, Quebec
Canada
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Marie-Josée Raboisson
University of Alberta
University of AlbertaEdmonton, Alberta
Canada
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Lisa Hornberger
The Hospital for Sick Children
The Hospital for Sick ChildrenToronto, Ontario
Canada
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The U of British Columbia
The U of British ColumbiaVancouver, British Columbia
Canada
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Shreya Moodley
Mount Sinai Hospital
Mount Sinai HospitalToronto, Ontario
Canada
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- Study Sponsored By
- The Hospital for Sick Children
- Participants Required
- More Information
- Study ID:
NCT03376438