COMPLETED

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2017-06-08
Study Completion:2025-03-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT03376438

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.

Ages Eligible for Study:16 Years to 50 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Mother has provided written informed consent to participate
  2. 2. Fetal AF or SVT with or without hydrops
  3. 3. Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
  4. * Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer
  5. * Tachycardia ≥ 170 bpm during +100% of time (≤ 30 0/7 weeks of gestation)
  6. * Tachycardia ≥ 280 bpm (irrespective of SVA duration)
  7. * SVT with fetal hydrops (irrespective of duration)
  8. 4. Gestational age \<36 0/7 weeks at time of enrollment
  9. 5. Singleton Pregnancy
  10. 6. Healthy mother with ± normal pre-treatment cardiovascular findings:
  11. * 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
  12. * Maternal resting heart rate ≥ 50 bpm
  13. * Maternal systolic BP ≥ 85 mmHg
  1. 1. Primary delivery for postnatal cardioversion
  2. 2. Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
  3. 3. Any maternal-fetal conditions associated with high odds of premature delivery and/or death
  4. 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)

Contacts and Locations

Principal Investigator

Edgar Jaeggi, MD, FRCPC
PRINCIPAL_INVESTIGATOR
The Hospital for Sick Children, Toronto, ON, Canada

Study Locations (Sites)

Phoenix Children's Hospital
Phoenix, Arizona, 85016
United States
University of California, San Francisco
San Francisco, California, 94158
United States
Children's Hospital Colorado
Denver, Colorado, 80205
United States
Children's National Medical Center
Washington, District of Columbia, 20010
United States
Johns Hopkins All Children's Hospital
St. Petersberg, Florida, 33701-4804
United States
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, 70121
United States
Boston Children's Hospital
Boston, Massachusetts, 02115
United States
Children's Health Care
Minnesota, Minnesota, 55404
United States
Children's Mercy Kansas City
Kansas City, Missouri, 64108
United States
Cohen Children's Medical Centre/Northwell Health - Lake Success
Lake Success, New York, 11040
United States
Columbia University
New York, New York, 10032
United States
Cincinnati Children's Hospital Medical Centre
Cincinnati, Ohio, 45229
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Inc Pediatric Cardiology of Austin Practice
Austin, Texas, 78722
United States
Texas Children's Hospital
Houston, Texas, 77030
United States
University of Utah
Salt Lake City, Utah, 84113
United States
West Virginia University Research Corporation
Morgantown, West Virginia, 26505
United States
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
United States

Collaborators and Investigators

Sponsor: Edgar Jaeggi

  • Edgar Jaeggi, MD, FRCPC, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2017-06-08
Study Completion Date2025-03-31

Study Record Updates

Study Start Date2017-06-08
Study Completion Date2025-03-31

Terms related to this study

Additional Relevant MeSH Terms

  • Atrial Flutter
  • Tachycardia, Supraventricular
  • Tachycardia, Atrial Ectopic
  • Tachycardia, Reciprocating
  • Tachycardia Atrial
  • Tachycardia, Atrioventricular Nodal Reentry
  • Tachycardia, Paroxysmal
  • Fetal Hydrops