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NCT03376438Completed

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

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

Source: ClinicalTrials.gov · Last updated 31 May 2025

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
330 (actual)
First submitted
27 Sept 2017
Start date
8 Jun 2017
Primary completion date
31 Mar 2025
Lead sponsor
Edgar Jaeggi
NCT number
NCT03376438

What you commit to

  • Study type: Observational
  • Participants enrolled: 330
  • From 8 Jun 2017 to the primary completion date, 31 Mar 2025
  • 41 sites in 14 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Any maternal-fetal conditions associated with high odds of premature delivery and/or death

Lab values

  • 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)

Other

  • Primary delivery for postnatal cardioversion
  • Antiarrhythmic fetal treatment for more than 2 days at time of enrollment

Who the study is looking for

  • 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

Age in the registry: 16 years to 50 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (41)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The Royal Women's Hospital
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MelbourneAustraliaUnknown status
Associação Beneficente Síria - Hospital do Coração
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São PauloBrazilUnknown status
Alberta Children's Hospital
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CalgaryCanadaUnknown status
University of Alberta
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EdmontonCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
CHU Saine-Justine
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MontrealCanadaUnknown status
The Hospital for Sick Children
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TorontoCanadaUnknown status
Mount Sinai Hospital
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TorontoCanadaUnknown status
The U of British Columbia
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VancouverCanadaUnknown status
Inselspital Universitätsspital Bern
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BernSwitzerlandUnknown status
University Hospital Brno
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BrnoCzechiaUnknown status
BCNatal - Hospital Sant Joan de Deu
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BarcelonaSpainUnknown status
Hospital Virgen de las Nieves
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GranadaSpainUnknown status
Pediatric Research Center
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HelsinkiFinlandUnknown status
Centre Hospitalier Universitaire
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GrenobleFranceUnknown status
Birmingham Women's and Children's NHS Foundation Trust
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BirminghamUnited KingdomUnknown status
St George's University Hospital Foundation Trust
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LondonUnited KingdomUnknown status
Queen Mary Hospital
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Hong KongHong Kong SAR ChinaUnknown status
Leiden University Medical Centre
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LeidenNetherlandsUnknown status
National Medical Research Center for Obstetrics, Gynecology and Perinatology
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MoscowRussiaUnknown status
Queen Silvia Children's Hospital
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GöteborgSwedenUnknown status
Lund University
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LundSwedenUnknown status
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
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SolnaSwedenUnknown status
Inc Pediatric Cardiology of Austin Practice
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AustinUnited StatesUnknown status
Boston Children's Hospital
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BostonUnited StatesUnknown status
Cincinnati Children's Hospital Medical Centre
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CincinnatiUnited StatesUnknown status
Children's Hospital Colorado
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DenverUnited StatesUnknown status
Texas Children's Hospital
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HoustonUnited StatesUnknown status
Children's Mercy Kansas City
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Kansas CityUnited StatesUnknown status
Cohen Children's Medical Centre/Northwell Health - Lake Success
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Lake SuccessUnited StatesUnknown status
Children's Hospital of Wisconsin
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MilwaukeeUnited StatesUnknown status
Children's Health Care
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MinneotaUnited StatesUnknown status
West Virginia University Research Corporation
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MorgantownUnited StatesUnknown status
Vanderbilt University Medical Center
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NashvilleUnited StatesUnknown status
John Ochsner Heart & Vascular Institute
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New OrleansUnited StatesUnknown status
Columbia University
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New YorkUnited StatesUnknown status
Phoenix Children s Hospital
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PhoenixUnited StatesUnknown status
Johns Hopkins All Children's Hospital
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Saint PetersbergUnited StatesUnknown status
University of Utah
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Salt Lake CityUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Children's National Medical Center
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Washington D.C.United StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.