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
Sites (41)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The Royal Women's Hospital Coordinator of this site? Confirm its status | Melbourne | Australia | Unknown status |
| Associação Beneficente Síria - Hospital do Coração Coordinator of this site? Confirm its status | São Paulo | Brazil | Unknown status |
| Alberta Children's Hospital Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| University of Alberta Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| London Health Sciences Centre Coordinator of this site? Confirm its status | London | Canada | Unknown status |
| CHU Saine-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| Mount Sinai Hospital Coordinator of this site? Confirm its status | Toronto | Canada | Unknown status |
| The U of British Columbia Coordinator of this site? Confirm its status | Vancouver | Canada | Unknown status |
| Inselspital Universitätsspital Bern Coordinator of this site? Confirm its status | Bern | Switzerland | Unknown status |
| University Hospital Brno Coordinator of this site? Confirm its status | Brno | Czechia | Unknown status |
| BCNatal - Hospital Sant Joan de Deu Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hospital Virgen de las Nieves Coordinator of this site? Confirm its status | Granada | Spain | Unknown status |
| Pediatric Research Center Coordinator of this site? Confirm its status | Helsinki | Finland | Unknown status |
| Centre Hospitalier Universitaire Coordinator of this site? Confirm its status | Grenoble | France | Unknown status |
| Birmingham Women's and Children's NHS Foundation Trust Coordinator of this site? Confirm its status | Birmingham | United Kingdom | Unknown status |
| St George's University Hospital Foundation Trust Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Queen Mary Hospital Coordinator of this site? Confirm its status | Hong Kong | Hong Kong SAR China | Unknown status |
| Leiden University Medical Centre Coordinator of this site? Confirm its status | Leiden | Netherlands | Unknown status |
| National Medical Research Center for Obstetrics, Gynecology and Perinatology Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Queen Silvia Children's Hospital Coordinator of this site? Confirm its status | Göteborg | Sweden | Unknown status |
| Lund University Coordinator of this site? Confirm its status | Lund | Sweden | Unknown status |
| Karolinska University Hospital, Astrid Lindgen Childrens Hospital Coordinator of this site? Confirm its status | Solna | Sweden | Unknown status |
| Inc Pediatric Cardiology of Austin Practice Coordinator of this site? Confirm its status | Austin | United States | Unknown status |
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Cincinnati Children's Hospital Medical Centre Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Children's Hospital Colorado Coordinator of this site? Confirm its status | Denver | United States | Unknown status |
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Unknown status |
| Children's Mercy Kansas City Coordinator of this site? Confirm its status | Kansas City | United States | Unknown status |
| Cohen Children's Medical Centre/Northwell Health - Lake Success Coordinator of this site? Confirm its status | Lake Success | United States | Unknown status |
| Children's Hospital of Wisconsin Coordinator of this site? Confirm its status | Milwaukee | United States | Unknown status |
| Children's Health Care Coordinator of this site? Confirm its status | Minneota | United States | Unknown status |
| West Virginia University Research Corporation Coordinator of this site? Confirm its status | Morgantown | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| John Ochsner Heart & Vascular Institute Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Columbia University Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Phoenix Children s Hospital Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Johns Hopkins All Children's Hospital Coordinator of this site? Confirm its status | Saint Petersberg | United States | Unknown status |
| University of Utah Coordinator of this site? Confirm its status | Salt Lake City | United States | Unknown status |
| University of California San Francisco Coordinator of this site? Confirm its status | San Francisco | United States | Unknown status |
| Children's National Medical Center Coordinator of this site? Confirm its status | Washington D.C. | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.