Clinical trial NCT03376438: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Official title: FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Flutter
Tachycardia, Supraventricular
Tachycardia, Atrial Ectopic
Tachycardia, Reciprocating
Tachycardia Atrial
Tachycardia, Atrioventricular Nodal Reentry
Tachycardia, Paroxysmal
Fetal Hydrops
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 330
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: Inclusion Criteria:

1. Mother has provided written informed consent to participate
2. Fetal AF or SVT with or without hydrops
3. 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)
4. Gestational age \<36 0/7 weeks at time of enrollment
5. Singleton Pregnancy
6. 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

Exclusion Criteria:

1. Primary delivery for postnatal cardioversion
2. Antiarrhythmic fetal treatment for more than 2 days at time of enrollment
3. Any maternal-fetal conditions associated with high odds of premature delivery and/or death
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)

Primary outcomes:
measure: Proportion of live-born children with a delivery at term and a normal cardiac rhythm
timeFrame: Term: 37 0/7 to 41 6/7 weeks
Secondary outcomes:
measure: Proportion of patients with cardioversion over time
timeFrame: 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
measure: Proportion of participants with treatment failure
timeFrame: 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
measure: Proportion of participants with arrhythmia-related death
timeFrame: From date of arrhythmia diagnosis or date of treatment start to 30 days of life
measure: Average gestational age at birth
timeFrame: At birth
measure: Birth weight (z-scores; centiles)
timeFrame: At birth
measure: Total days of treatment related maternal and neonatal hospitalizations
timeFrame: From date of diagnosis or treatment begin to 30 days of life
measure: Maternal prevalence of pregnancy/treatment-related AEs and outcomes
timeFrame: Diagnosis to birth
measure: Maternal prevalence of adverse events and outcome
timeFrame: From date of treatment begin to 30 days of life
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's Hospital
state: Arizona
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
city: Denver
country: United States
facility: Children's Hospital Colorado
state: Colorado
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: St. Petersberg
country: United States
facility: Johns Hopkins All Children's Hospital
state: Florida
city: New Orleans
country: United States
facility: John Ochsner Heart & Vascular Institute
state: Louisiana
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Minnesota
country: United States
facility: Children's Health Care
state: Minnesota
city: Kansas City
country: United States
facility: Children's Mercy Kansas City
state: Missouri
city: Lake Success
country: United States
facility: Cohen Children's Medical Centre/Northwell Health - Lake Success
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Centre
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Austin
country: United States
facility: Inc Pediatric Cardiology of Austin Practice
state: Texas
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Morgantown
country: United States
facility: West Virginia University Research Corporation
state: West Virginia
city: Milwaukee
country: United States
facility: Children's Hospital of Wisconsin
state: Wisconsin
city: Melbourne
country: Australia
facility: The Royal Women's Hospital
city: São Paulo
country: Brazil
facility: Associação Beneficente Síria - Hospital do Coração
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
city: Vancouver
country: Canada
facility: The U of British Columbia
state: British Columbia
city: Calgary
country: Canada
facility: Alberta Children's Hospital
state: Ontario
city: London
country: Canada
facility: London Health Sciences Centre
state: Ontario
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
city: Montréal
country: Canada
facility: CHU Saine-Justine
state: Quebec
city: Brno
country: Czechia
facility: University Hospital Brno
city: Helsinki
country: Finland
facility: Pediatric Research Center
city: Grenoble
country: France
facility: Centre Hospitalier Universitaire
state: Alpes
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Leiden
country: Netherlands
facility: Leiden University Medical Centre
city: Moscow
country: Russian Federation
facility: National Medical Research Center for Obstetrics, Gynecology and Perinatology
city: Barcelona
country: Spain
facility: BCNatal - Hospital Sant Joan de Deu
city: Grenada
country: Spain
facility: Hospital Virgen de las Nieves
city: Göteborg
country: Sweden
facility: Queen Silvia Children's Hospital
state: Skåne County
city: Lund
country: Sweden
facility: Lund University
city: Solna
country: Sweden
facility: Karolinska University Hospital, Astrid Lindgen Childrens Hospital
city: Bern
country: Switzerland
facility: Inselspital Universitatsspital Bern
city: Birmingham
country: United Kingdom
facility: Birmingham Women's and Children's NHS Foundation Trust
city: London
country: United Kingdom
facility: St George's University Hospital Foundation Trust
Study officials:
affiliation: The Hospital for Sick Children, Toronto, ON, Canada
name: Edgar Jaeggi, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References: