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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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Conditions de participation

  • Sexe:

    FEMALE
  • Âges admissibles:

    16 to 50

Critères de participation

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)

Lieu de l'étude

London Health Sciences Centre
London Health Sciences Centre
London, Ontario
Canada

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Primary Contact

Michael Grattan

Alberta Children's Hospital
Alberta Children's Hospital
Calgary, Ontario
Canada

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Primary Contact

Deborah Fruitman

CHU Saine-Justine
CHU Saine-Justine
Montréal, Quebec
Canada

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Primary Contact

Marie-Josée Raboisson

University of Alberta
University of Alberta
Edmonton, Alberta
Canada

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Primary Contact

Lisa Hornberger

The Hospital for Sick Children
The Hospital for Sick Children
Toronto, Ontario
Canada

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Primary Contact

Edgar Jaeggi, MD

[email protected]
416-813-7500
Backup Contact

Aisha Dar, CRPM

[email protected]
416-813-7654
The U of British Columbia
The U of British Columbia
Vancouver, British Columbia
Canada

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Primary Contact

Shreya Moodley

Mount Sinai Hospital
Mount Sinai Hospital
Toronto, Ontario
Canada

Contactez l'équipe d'étude

Primary Contact

Edgar Jaeggi, MD

[email protected]
4165082546
Étude parrainée par
The Hospital for Sick Children
Participants recherchés
Plus d'informations
ID de l'étude: NCT03376438