Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
- Conditions
- Fetal HydropsTachycardia, ParoxysmalAtrial FlutterTachycardia, SupraventricularTachycardia, Atrial EctopicTachycardia, ReciprocatingTachycardia AtrialTachycardia, Atrioventricular Nodal Reentry
- Interventions
- Other: Prospective observational cohorts
- Registration Number
- NCT03376438
- Lead Sponsor
- Edgar Jaeggi
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 400
-
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
- Primary delivery for postnatal cardioversion
- Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
- Any maternal-fetal conditions associated with high odds of premature delivery and/or death
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Prospective observational cohorts 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
- Primary Outcome Measures
Name Time Method Proportion of live-born children with a delivery at term and a normal cardiac rhythm Term: 37 0/7 to 41 6/7 weeks
- Secondary Outcome Measures
Name Time Method Proportion of participants with treatment failure 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.
Proportion of patients with cardioversion 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 Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
Total days of treatment related maternal and neonatal hospitalizations From date of diagnosis or treatment begin to 30 days of life Average gestational age at birth At birth Proportion of participants with arrhythmia-related death 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
Birth weight (z-scores; centiles) At birth Maternal prevalence of pregnancy/treatment-related AEs and outcomes Diagnosis to birth Maternal prevalence of adverse events and outcome From date of treatment begin to 30 days of life
Trial Locations
- Locations (41)
West Virginia University Research Corporation
🇺🇸Morgantown, West Virginia, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins All Children's Hospital
🇺🇸Saint Petersburg, Florida, United States
Children's Health Care
🇺🇸Minnesota, Minnesota, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States
Cohen Children's Medical Centre/Northwell Health - Lake Success
🇺🇸Lake Success, New York, United States
Columbia University
🇺🇸New York, New York, United States
Texas Children's Hospital
🇺🇸Houston, Texas, United States
University of Alberta
🇨🇦Edmonton, Alberta, Canada
The U of British Columbia
🇨🇦Vancouver, British Columbia, Canada
The Royal Women's Hospital
🇦🇺Melbourne, Australia
Associação Beneficente Síria - Hospital do Coração
🇧🇷São Paulo, Brazil
London Health Sciences Centre
🇨🇦London, Ontario, Canada
Alberta Children's Hospital
🇨🇦Calgary, Ontario, Canada
The Hospital for Sick Children
🇨🇦Toronto, Ontario, Canada
CHU Saine-Justine
🇨🇦Montréal, Quebec, Canada
University Hospital Brno
🇨🇿Brno, Czechia
Pediatric Research Center
🇫🇮Helsinki, Finland
Centre Hospitalier Universitaire
🇫🇷Grenoble, Alpes, France
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Leiden University Medical Centre
🇳🇱Leiden, Netherlands
National Medical Research Center for Obstetrics, Gynecology and Perinatology
🇷🇺Moscow, Russian Federation
BCNatal - Hospital Sant Joan de Deu
🇪🇸Barcelona, Spain
Hospital Virgen de las Nieves
🇪🇸Grenada, Spain
Queen Silvia Children's Hospital
🇸🇪Göteborg, Skåne County, Sweden
Lund University
🇸🇪Lund, Sweden
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
🇸🇪Solna, Sweden
Inselspital Universitatsspital Bern
🇨🇭Bern, Switzerland
Birmingham Women's and Children's NHS Foundation Trust
🇬🇧Birmingham, United Kingdom
St George's University Hospital Foundation Trust
🇬🇧London, United Kingdom
Mount Sinai Hospital
🇨🇦Toronto, Ontario, Canada
Phoenix Children's Hospital
🇺🇸Phoenix, Arizona, United States
University of California, San Francisco
🇺🇸San Francisco, California, United States
Children's Hospital Colorado
🇺🇸Denver, Colorado, United States
John Ochsner Heart & Vascular Institute
🇺🇸New Orleans, Louisiana, United States
Children's Mercy Kansas City
🇺🇸Kansas City, Missouri, United States
Cincinnati Children's Hospital Medical Centre
🇺🇸Cincinnati, Ohio, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Inc Pediatric Cardiology of Austin Practice
🇺🇸Austin, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States