Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Atrial Flutter Clinical Trial

— FAST Registry  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03376438
• Other study ID #: 1000048953
• Status: Recruiting
• Start date: June 8, 2017
• Est. completion date: May 31, 2025

Study information

• Verified date: May 2024
• Source: The Hospital for Sick Children
• Contact: Diana Balmer-Minnes, BSc, CCRP
• Phone: 416-813-7654
• Email: FAST.Trial[@]sickkids.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: May 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 16 Years to 50 Years

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

Other:
• Prospective observational cohorts
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.

Locations

Country	Name	City	State
Australia	The Royal Women's Hospital	Melbourne
Brazil	Associação Beneficente Síria - Hospital do Coração	São Paulo
Canada	Alberta Children's Hospital	Calgary	Ontario
Canada	University of Alberta	Edmonton	Alberta
Canada	London Health Sciences Centre	London	Ontario
Canada	CHU Saine-Justine	Montréal	Quebec
Canada	Mount Sinai Hospital	Toronto	Ontario
Canada	The Hospital for Sick Children	Toronto	Ontario
Canada	The U of British Columbia	Vancouver	British Columbia
Czechia	University Hospital Brno	Brno
Finland	Pediatric Research Center	Helsinki
France	Centre Hospitalier Universitaire	Grenoble	Alpes
Hong Kong	Queen Mary Hospital	Hong Kong
Netherlands	Leiden University Medical Centre	Leiden
Russian Federation	National Medical Research Center for Obstetrics, Gynecology and Perinatology	Moscow
Spain	BCNatal - Hospital Sant Joan de Deu	Barcelona
Spain	Hospital Virgen de las Nieves	Grenada
Sweden	Queen Silvia Children's Hospital	Göteborg	Skåne County
Sweden	Lund University	Lund
Sweden	Karolinska University Hospital, Astrid Lindgen Childrens Hospital	Solna
Switzerland	Inselspital Universitatsspital Bern	Bern
United Kingdom	Birmingham Women's and Children's NHS Foundation Trust	Birmingham
United Kingdom	St George's University Hospital Foundation Trust	London
United States	Inc Pediatric Cardiology of Austin Practice	Austin	Texas
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Cincinnati Children's Hospital Medical Centre	Cincinnati	Ohio
United States	Children's Hospital Colorado	Denver	Colorado
United States	Texas Children's Hospital	Houston	Texas
United States	Children's Mercy Kansas City	Kansas City	Missouri
United States	Cohen Children's Medical Centre/Northwell Health - Lake Success	Lake Success	New York
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin
United States	Children's Health Care	Minnesota	Minnesota
United States	West Virginia University Research Corporation	Morgantown	West Virginia
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	John Ochsner Heart & Vascular Institute	New Orleans	Louisiana
United States	John Ochsner Heart & Vascular Institute	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Phoenix Children's Hospital	Phoenix	Arizona
United States	Johns Hopkins All Children's Hospital	Saint Petersburg	Florida
United States	University of Utah	Salt Lake City	Utah
United States	University of California, San Francisco	San Francisco	California
United States	Children's National Medical Center	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Edgar Jaeggi

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Canada,  Czechia,  Finland,  France,  Hong Kong,  Netherlands,  Russian Federation,  Spain,  Sweden,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Proportion of patients with cardioversion over time	Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm 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
Secondary	Proportion of participants with treatment failure	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.	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
Secondary	Proportion of participants with arrhythmia-related death	Number of participants with arrhythmia-related death compared to other outcomes	From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Secondary	Average gestational age at birth		At birth
Secondary	Birth weight (z-scores; centiles)		At birth
Secondary	Total days of treatment related maternal and neonatal hospitalizations		From date of diagnosis or treatment begin to 30 days of life
Secondary	Maternal prevalence of pregnancy/treatment-related AEs and outcomes		Diagnosis to birth
Secondary	Maternal prevalence of adverse events and outcome		From date of treatment begin to 30 days of life