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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT03376438




Registration number
NCT03376438
Ethics application status
Date submitted
27/09/2017
Date registered
18/12/2017

Titles & IDs
Public title
Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Scientific title
FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
Secondary ID [1] 0 0
1000048953
Universal Trial Number (UTN)
Trial acronym
FAST Registry
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Atrial Flutter 0 0
Tachycardia, Supraventricular 0 0
Tachycardia, Atrial Ectopic 0 0
Tachycardia, Reciprocating 0 0
Tachycardia Atrial 0 0
Tachycardia, Atrioventricular Nodal Reentry 0 0
Tachycardia, Paroxysmal 0 0
Fetal Hydrops 0 0
Condition category
Condition code
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders
Reproductive Health and Childbirth 0 0 0 0
Complications of newborn
Cardiovascular 0 0 0 0
Other cardiovascular diseases
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Other interventions - 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


Other interventions: 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.
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Timepoint [1] 0 0
Term: 37 0/7 to 41 6/7 weeks
Secondary outcome [1] 0 0
Proportion of patients with cardioversion over time
Timepoint [1] 0 0
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 outcome [2] 0 0
Proportion of participants with treatment failure
Timepoint [2] 0 0
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 outcome [3] 0 0
Proportion of participants with arrhythmia-related death
Timepoint [3] 0 0
From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Secondary outcome [4] 0 0
Average gestational age at birth
Timepoint [4] 0 0
At birth
Secondary outcome [5] 0 0
Birth weight (z-scores; centiles)
Timepoint [5] 0 0
At birth
Secondary outcome [6] 0 0
Total days of treatment related maternal and neonatal hospitalizations
Timepoint [6] 0 0
From date of diagnosis or treatment begin to 30 days of life
Secondary outcome [7] 0 0
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Timepoint [7] 0 0
Diagnosis to birth
Secondary outcome [8] 0 0
Maternal prevalence of adverse events and outcome
Timepoint [8] 0 0
From date of treatment begin to 30 days of life

Eligibility
Key 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
Minimum age
16 Years
Maximum age
50 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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)

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
8/06/2017
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/05/2025
Actual
Sample size
Target
400
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
The Royal Women's Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
District of Columbia
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Louisiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Minnesota
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
New York
Country [11] 0 0
United States of America
State/province [11] 0 0
Ohio
Country [12] 0 0
United States of America
State/province [12] 0 0
Tennessee
Country [13] 0 0
United States of America
State/province [13] 0 0
Texas
Country [14] 0 0
United States of America
State/province [14] 0 0
Utah
Country [15] 0 0
United States of America
State/province [15] 0 0
West Virginia
Country [16] 0 0
United States of America
State/province [16] 0 0
Wisconsin
Country [17] 0 0
Brazil
State/province [17] 0 0
São Paulo
Country [18] 0 0
Canada
State/province [18] 0 0
Alberta
Country [19] 0 0
Canada
State/province [19] 0 0
British Columbia
Country [20] 0 0
Canada
State/province [20] 0 0
Ontario
Country [21] 0 0
Canada
State/province [21] 0 0
Quebec
Country [22] 0 0
Czechia
State/province [22] 0 0
Brno
Country [23] 0 0
Finland
State/province [23] 0 0
Helsinki
Country [24] 0 0
France
State/province [24] 0 0
Alpes
Country [25] 0 0
Hong Kong
State/province [25] 0 0
Hong Kong
Country [26] 0 0
Netherlands
State/province [26] 0 0
Leiden
Country [27] 0 0
Russian Federation
State/province [27] 0 0
Moscow
Country [28] 0 0
Spain
State/province [28] 0 0
Barcelona
Country [29] 0 0
Spain
State/province [29] 0 0
Grenada
Country [30] 0 0
Sweden
State/province [30] 0 0
Skåne County
Country [31] 0 0
Sweden
State/province [31] 0 0
Lund
Country [32] 0 0
Sweden
State/province [32] 0 0
Solna
Country [33] 0 0
Switzerland
State/province [33] 0 0
Bern
Country [34] 0 0
United Kingdom
State/province [34] 0 0
Birmingham
Country [35] 0 0
United Kingdom
State/province [35] 0 0
London

Funding & Sponsors
Primary sponsor type
Other
Name
Edgar Jaeggi
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Edgar Jaeggi, MD, FRCPC
Address 0 0
The Hospital for Sick Children, Toronto, ON, Canada
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Diana Balmer-Minnes, BSc, CCRP
Address 0 0
Country 0 0
Phone 0 0
416-813-7654
Fax 0 0
Email 0 0
FAST.Trial@sickkids.ca
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT03376438