Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

NCT03376438 | Completed

• 1 other identifier: 1000048953
• Study Type: observational
• Target: 330
• Locations: 14 countries
• Sites: 41

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• 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

• 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

• Proportion of participants with arrhythmia-related death

  From date of arrhythmia diagnosis or date of treatment start to 30 days of life

• Average gestational age at birth

  At birth

• Birth weight (z-scores; centiles)

  At birth

Study Arms (1)

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

Interventions

Prospective observational cohorts OTHER

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.

Also known as: Non-randomized antiarrhythmic fetal drug therapy

Prospective observational cohorts

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Edgar Jaeggi: lead

Study Sites (41)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

University of California, San Francisco

San Francisco, California, 94158, United States

Location

Children's Hospital Colorado

Denver, Colorado, 80205, United States

Location

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Johns Hopkins All Children's Hospital

Saint Petersberg, Florida, 33701-4804, United States

Location

John Ochsner Heart & Vascular Institute

New Orleans, Louisiana, 70121, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Children's Health Care

Minneota, Minnesota, 55404, United States

Location

Children's Mercy Kansas City

Kansas City, Missouri, 64108, United States

Location

Cohen Children's Medical Centre/Northwell Health - Lake Success

Lake Success, New York, 11040, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Cincinnati Children's Hospital Medical Centre

Cincinnati, Ohio, 45229, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Inc Pediatric Cardiology of Austin Practice

Austin, Texas, 78722, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84113, United States

Location

West Virginia University Research Corporation

Morgantown, West Virginia, 26505, United States

Location

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

The Royal Women's Hospital

Melbourne, Australia

Location

Associação Beneficente Síria - Hospital do Coração

São Paulo, 04004- 030, Brazil

Location

University of Alberta

Edmonton, Alberta, Canada

Location

The U of British Columbia

Vancouver, British Columbia, Canada

Location

Alberta Children's Hospital

Calgary, Ontario, T3B 6A8, Canada

Location

London Health Sciences Centre

London, Ontario, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G1X8, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, Canada

Location

CHU Saine-Justine

Montreal, Quebec, H3T 1C5, Canada

Location

University Hospital Brno

Brno, Czechia

Location

Pediatric Research Center

Helsinki, Finland

Location

Centre Hospitalier Universitaire

Grenoble, Alpes, 38043, France

Location

Queen Mary Hospital

Hong Kong, Hong Kong, Hong Kong

Location

Leiden University Medical Centre

Leiden, Netherlands

Location

National Medical Research Center for Obstetrics, Gynecology and Perinatology

Moscow, Russia

Location

BCNatal - Hospital Sant Joan de Deu

Barcelona, Spain

Location

Hospital Virgen de las Nieves

Granada, Spain

Location

Queen Silvia Children's Hospital

Göteborg, Skåne County, 416 85, Sweden

Location

Lund University

Lund, Sweden

Location

Karolinska University Hospital, Astrid Lindgen Childrens Hospital

Solna, Sweden

Location

Inselspital Universitatsspital Bern

Bern, Switzerland

Location

Birmingham Women's and Children's NHS Foundation Trust

Birmingham, United Kingdom

Location

St George's University Hospital Foundation Trust

London, United Kingdom

Location

MeSH Terms

Conditions

Atrial Flutter; Tachycardia, Supraventricular; Tachycardia, Ectopic Atrial; Tachycardia, Reciprocating; Tachycardia, Atrioventricular Nodal Reentry; Tachycardia, Paroxysmal; Hydrops Fetalis

Condition Hierarchy (Ancestors)

Arrhythmias, Cardiac; Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Tachycardia; Cardiac Conduction System Disease; Erythroblastosis, Fetal; Fetal Diseases; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hematologic Diseases; Hemic and Lymphatic Diseases; alpha-Thalassemia; Thalassemia; Hemoglobinopathies; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn; Immune System Diseases; Edema; Signs and Symptoms

Study Officials

• Edgar Jaeggi, MD, FRCPC

  The Hospital for Sick Children, Toronto, ON, Canada

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Associate Scientist Emeritus Edgar Jaeggi, MD FRCPC

Study Record Dates

• First Submitted: September 27, 2017
• First Posted: December 18, 2017
• Study Start: June 8, 2017
• Primary Completion: March 31, 2025
• Study Completion: March 31, 2025
• Last Updated: May 31, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1); FI (1); CA (7); US (18); CZ (1); FR (1); RU (1); AU (1); HK (1); ES (2); NL (1); SE (3); CH (1); GB (2)