Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia (FAST Registry)

January 29, 2024 updated by: Edgar Jaeggi, The Hospital for Sick Children

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 pregnancy is complicated by an abnormally fast heart rate up to 300 beats per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although fetal SVA, including AF and other forms of SVT, is the most common cause of intended in-utero fetal therapy, our knowledge of drug effects on the baby and the co-treated mother is still limited. The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial to address this knowledge gap in order to guide future patient management to the best of care.

FAST Trial components include:

  1. A prospective Registry (FAST Registry; see this document) as well as
  2. Three prospective Randomized Clinical Trials (FAST RCTs; see ClinicalTrials.gov #NCT02624765).

The FAST Registry is a prospective observational cohort study to determine the impact of different prenatal treatment strategies on patients diagnosed with fetal AF without hydrops, AF with hydrops, SVT without hydrops, and SVT with hydrops. All management decisions including the choice of antiarrhythmic medication or the decision to observe without treatment are at the discretion of the treating physician. The primary outcome measure will be the proportion of term deliveries of live-born children with a normal cardiac rhythm. Secondary outcome measures include the efficacy of 1st line, 2nd line, 3rd line, and maintenance drug therapy in controlling the different arrhythmias prior to birth and patient safety.

Participation of a site in the FAST Registry requires experience with the perinatal management of fetal AF and SVT, local REB/IRB approval and an executed legal contract with the Hospital for Sick Children, Toronto.

Participation of a patient in the FAST Registry requires that all inclusion and none of the exclusion criteria are fulfilled (see below). Enrollment is possible within 2 days of the arrhythmia diagnosis and the initial management decision.

Study Type

Observational

Enrollment (Estimated)

400

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
      • Melbourne, Australia
        • Recruiting
        • The Royal Women's Hospital
        • Contact:
          • Darren Hutchinson
  • Brazil
      • São Paulo, Brazil, 04004- 030
        • Recruiting
        • Associação Beneficente Síria - Hospital do Coração
        • Contact:
          • Simone Pedra
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
        • Recruiting
        • University of Alberta
        • Contact:
          • Lisa Hornberger
    • British Columbia
      • Vancouver, British Columbia, Canada
        • Recruiting
        • The U of British Columbia
        • Contact:
          • Shreya Moodley
    • Ontario
      • Calgary, Ontario, Canada, T3B 6A8
        • Recruiting
        • Alberta Children's Hospital
        • Contact:
          • Deborah Fruitman
      • London, Ontario, Canada
        • Recruiting
        • London Health Sciences Centre
        • Contact:
          • Michael Grattan
      • Toronto, Ontario, Canada
      • Toronto, Ontario, Canada, M5G1X8
        • Recruiting
        • The Hospital for Sick Children
        • Sub-Investigator:
          • Vitor Guerra, MD
        • Principal Investigator:
          • Edgar Jaeggi, MD
        • Contact:
        • Contact:
    • Quebec
      • Montréal, Quebec, Canada, H3T 1C5
        • Recruiting
        • CHU Saine-Justine
        • Contact:
          • Marie-Josée Raboisson
  • Czechia
      • Brno, Czechia
        • Terminated
        • University Hospital Brno
  • Finland
      • Helsinki, Finland
        • Recruiting
        • Pediatric Research Center
        • Contact:
          • Taisto Sarkola
  • France
    • Alpes
      • Grenoble, Alpes, France, 38043
        • Recruiting
        • Centre Hospitalier Universitaire
        • Contact:
          • Matthias Lachaud, MD
  • Hong Kong
      • Hong Kong, Hong Kong
        • Recruiting
        • Queen Mary Hospital
        • Contact:
          • Pak-cheung Chow, MD
  • Netherlands
      • Leiden, Netherlands
        • Recruiting
        • Leiden University Medical Centre
        • Contact:
          • Nico Blom
  • Russian Federation
      • Moscow, Russian Federation
        • Recruiting
        • National Medical Research Center for Obstetrics, Gynecology and Perinatology
        • Contact:
          • Katerina Bockeria
  • Spain
      • Barcelona, Spain
        • Recruiting
        • BCNatal - Hospital Sant Joan de Deu
        • Contact:
          • Eduardo Gratacos
        • Contact:
          • Olga Gomez
      • Grenada, Spain
        • Recruiting
        • Hospital Virgen de las Nieves
        • Contact:
          • Francesca Perin
  • Sweden
      • Lund, Sweden
        • Recruiting
        • Lund University
        • Contact:
          • Misha Bhat
      • Solna, Sweden
        • Recruiting
        • Karolinska University Hospital, Astrid Lindgen Childrens Hospital
        • Contact:
          • Hakan Eliasson
    • Skåne County
      • Göteborg, Skåne County, Sweden, 416 85
        • Recruiting
        • Queen Silvia Children's Hospital
        • Contact:
          • Annika Öhman
  • Switzerland
      • Bern, Switzerland
        • Terminated
        • Inselspital Universitätsspital Bern
  • United Kingdom
      • Birmingham, United Kingdom
        • Terminated
        • Birmingham Women's and Children's NHS Foundation Trust
      • London, United Kingdom
        • Terminated
        • St George's University Hospital Foundation Trust
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Recruiting
        • Phoenix Children's Hospital
        • Contact:
          • Chris Lindblade, MD
    • California
      • San Francisco, California, United States, 94158
        • Recruiting
        • University of California, San Francisco
        • Contact:
          • Anita Moon-Grady
    • Colorado
      • Denver, Colorado, United States, 80205
        • Recruiting
        • Children's Hospital Colorado
        • Contact:
          • Bettina Cuneo
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Medical Center
        • Contact:
          • Mary Donofrio
    • Florida
      • Saint Petersburg, Florida, United States, 33701-4804
        • Recruiting
        • Johns Hopkins All Children's Hospital
        • Contact:
          • Grace Freire
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Recruiting
        • John Ochsner Heart & Vascular Institute
        • Contact:
          • Kamill Del Toro, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Boston Children's Hospital
        • Contact:
          • Audrey Dionne, MD
    • Minnesota
      • Minnesota, Minnesota, United States, 55404
        • Recruiting
        • Children's Health Care
        • Contact:
          • Lisa Howley, MD
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Children's Mercy Kansas City
        • Contact:
          • Nitin Madan
    • New York
      • Lake Success, New York, United States, 11040
        • Recruiting
        • Cohen Children's Medical Centre/Northwell Health - Lake Success
        • Contact:
          • Elizabeth Mitchell
      • New York, New York, United States, 10032
        • Recruiting
        • Columbia University
        • Contact:
          • Stephanie Levasseur
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Centre
        • Contact:
          • Allison Divanovic
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University Medical Center
        • Contact:
          • Stacy Stratemann Killen, MD
    • Texas
      • Austin, Texas, United States, 78722
        • Recruiting
        • Inc Pediatric Cardiology of Austin Practice
        • Contact:
          • Jeanine Schuman-McCoy, MS
      • Houston, Texas, United States, 77030
        • Recruiting
        • Texas Children's Hospital
        • Contact:
          • Shaine Morris
    • Utah
      • Salt Lake City, Utah, United States, 84113
        • Recruiting
        • University of Utah
        • Contact:
          • Nelangi Pinto
    • West Virginia
      • Morgantown, West Virginia, United States, 26505
        • Recruiting
        • West Virginia University Research Corporation
        • Contact:
          • Phil Saul
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Children's Hospital of Wisconsin
        • Contact:
          • Erika Peterson
        • Contact:
          • Janette Strasburger

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.

Eligibility Criteria

Ages Eligible for Study

16 years to 50 years (Child, Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Enrollment into the Registry is possible within maximally 2 days of the fetal SVA diagnosis and management decision to treat or not to treat. If a mother elects participation in the Registry, her treating physician will continue to provide care in accordance with clinical practice at the site and will decide all therapy including close observation without or with immediate prenatal treatment.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Prospective observational cohorts
1) Atrial flutter without fetal hydrops; 2) Atrial flutter with fetal hydrops; 3) Supraventricular tachycardia without fetal hydrops; and 4) Supraventricular tachycardia with fetal hydrops
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.
Other Names:
  • Non-randomized antiarrhythmic fetal drug therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Time Frame: Term: 37 0/7 to 41 6/7 weeks
Term: 37 0/7 to 41 6/7 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average gestational age at birth
Time Frame: At birth
At birth
Proportion of patients with cardioversion over time
Time Frame: From date of SVA dignosis until the date of first documented cardioversion or until the date of delivery/fetal death without cardioversion, whichever comes first, assessed up to 30 gestational weeks
Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
From date of SVA dignosis until the date of first documented cardioversion or until the date of delivery/fetal death without cardioversion, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with treatment failure
Time Frame: From date of treatment start until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks
Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death.
From date of treatment start until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks
Proportion of participants with arrhythmia-related death
Time Frame: From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Number of participants with arrhythmia-related death compared to other outcomes
From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Birth weight (z-scores; centiles)
Time Frame: At birth
At birth
Total days of treatment related maternal and neonatal hospitalizations
Time Frame: From date of diagnosis or treatment begin to 30 days of life
From date of diagnosis or treatment begin to 30 days of life
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Time Frame: Diagnosis to birth
Diagnosis to birth
Maternal prevalence of adverse events and outcome
Time Frame: From date of treatment begin to 30 days of life
From date of treatment begin to 30 days of life

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Hospital for Sick Children

Collaborators

Labatt Family Heart Centre

Investigators

  • Principal Investigator: Edgar Jaeggi, MD, FRCPC, The Hospital for Sick Children, Toronto, ON, Canada

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 8, 2017

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

May 31, 2025

Study Registration Dates

First Submitted

September 27, 2017

First Submitted That Met QC Criteria

December 15, 2017

First Posted (Actual)

December 18, 2017

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 29, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1000048953

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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