Atrial FlutterFAST RegistryNCT03376438
Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
An observational study of Atrial Flutter and Tachycardia, Supraventricular, run by Edgar Jaeggi at 41 sites in 14 countries.
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). Read more about this study
- Who is it for?
- Ages 16 to 50 years, women only
- Conditions the study is for
- Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Atrial Ectopic
- What is being tested?
- Prospective observational cohorts
- How many people
- 330 participants
- Where
- 41 sitesin 14 countries
- Study dates
- 8 Jun 2017to 31 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 50 years
- Women only
- No healthy volunteers
- Child, Adult
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.
Who may be able to join
- 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)
Show all 13Show fewer
- 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
Who cannot join
- 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)
Trial locations and contacts
41 sites in 14 countries.
41 sites in 14 countries
United States18 sites
Inc Pediatric Cardiology of Austin Practice
Austin, Texas, 78722
Boston Children's Hospital
Boston, Massachusetts, 02115
Cincinnati Children's Hospital Medical Centre
Cincinnati, Ohio, 45229
Children's Hospital Colorado
Denver, Colorado, 80205
Texas Children's Hospital
Houston, Texas, 77030
Children's Mercy Kansas City
Kansas City, Missouri, 64108
Cohen Children's Medical Centre/Northwell Health - Lake Success
Lake Success, New York, 11040
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, 53226
Children's Health Care
Minneota, Minnesota, 55404
West Virginia University Research Corporation
Morgantown, West Virginia, 26505
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
John Ochsner Heart & Vascular Institute
New Orleans, Louisiana, 70121
Columbia University
New York, New York, 10032
Phoenix Children's Hospital
Phoenix, Arizona, 85016
Johns Hopkins All Children's Hospital
Saint Petersberg, Florida, 33701-4804
University of Utah
Salt Lake City, Utah, 84113
University of California, San Francisco
San Francisco, California, 94158
Children's National Medical Center
Washington D.C., District of Columbia, 20010
Canada7 sites
Alberta Children's Hospital
Calgary, Ontario, T3B 6A8
University of Alberta
Edmonton, Alberta
London Health Sciences Centre
London, Ontario
CHU Saine-Justine
Montreal, Quebec, H3T 1C5
The Hospital for Sick Children
Toronto, Ontario, M5G1X8
Mount Sinai Hospital
Toronto, Ontario
The U of British Columbia
Vancouver, British Columbia
Sweden3 sites
Queen Silvia Children's Hospital
Göteborg, Skåne County, 416 85
Lund University
Lund
Karolinska University Hospital, Astrid Lindgen Childrens Hospital
Solna
Spain2 sites
BCNatal - Hospital Sant Joan de Deu
Barcelona
Hospital Virgen de las Nieves
Granada
United Kingdom2 sites
Birmingham Women's and Children's NHS Foundation Trust
Birmingham
St George's University Hospital Foundation Trust
London
Brazil1 site
Associação Beneficente Síria - Hospital do Coração
São Paulo, 04004- 030
Russia1 site
National Medical Research Center for Obstetrics, Gynecology and Perinatology
Moscow
About this study
Official title: FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
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.
Read the 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:
- A prospective Registry (FAST Registry; see this document) as well as
- 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.
- Conditions
- Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Atrial Ectopic, Tachycardia, Reciprocating, Tachycardia Atrial, Tachycardia, Atrioventricular Nodal Reentry
- Being tested
- Prospective observational cohorts
- Medical subject headings
- Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Ectopic Atrial, Tachycardia, Reciprocating, Tachycardia, Atrioventricular Nodal Reentry, Tachycardia, Paroxysmal, Hydrops Fetalis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prospective observational cohortsOther
Also called Non-randomized antiarrhythmic fetal drug therapy
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Prospective observational cohorts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Measured: Term: 37 0/7 to 41 6/7 weeks
Secondary outcomes (8)
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
Measured: 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
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.
Measured: 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
Number of participants with arrhythmia-related death compared to other outcomes
Measured: From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Average gestational age at birth
Measured: At birth
Birth weight (z-scores; centiles)
Measured: At birth
Total days of treatment related maternal and neonatal hospitalizations
Measured: From date of diagnosis or treatment begin to 30 days of life
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Measured: Diagnosis to birth
Maternal prevalence of adverse events and outcome
Measured: From date of treatment begin to 30 days of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2017
- Study start8 Jun 2017
- Primary completion31 Mar 2025
- Study completion31 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atrial FlutterStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Edgar Jaeggi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Edgar Jaeggi, The Hospital for Sick Children
- Investigators
- Edgar Jaeggi, MD, FRCPC, Principal investigator, The Hospital for Sick Children, Toronto, ON, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03376438
- Sponsor's protocol ID
- 1000048953
- Acronym
- FAST Registry
- Status last verified
- Apr 2025
- First submitted
- 27 Sep 2017
- Last updated
- 31 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- FAST Trial Registry: Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia
- ClinicalTrials.gov ID
- NCT03376438
- Acronym / sponsor ID
- FAST Registry / 1000048953
- Conditions
- Atrial Flutter, Tachycardia, Supraventricular, Tachycardia, Atrial Ectopic, Tachycardia, Reciprocating, Tachycardia Atrial, Tachycardia, Atrioventricular Nodal Reentry
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Edgar JaeggiUniversity, hospital or other
- Study start
- 8 Jun 2017 (actual)
- Primary completion
- 31 Mar 2025 (actual)
- Study completion
- 31 Mar 2025 (actual)
- First posted
- 18 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- A prospective Registry (FAST Registry; see this document) as well as
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prospective observational cohorts | – | Other: Prospective observational cohorts1) Atrial flutter without fetal hydrops; 2) Atrial flutter with fetal hydrops; 3) Supraventricular tachycardia without fetal hydrops; and 4) Supraventricular tachycardia with fetal hydrops |
Who may qualify
- Ages
- 16 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- 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.
Key inclusion criteria (13 listed)
- 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:
- Gestational age <36 0/7 weeks at time of enrollment
- Singleton Pregnancy
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prospective observational cohortsAlso: Non-randomized antiarrhythmic fetal drug therapyPatients 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. | Other | Prospective observational cohorts |
Primary outcome
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Time frame: Term: 37 0/7 to 41 6/7 weeks
8 secondary outcomes
Proportion of patients with cardioversion over time
Time frame: 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
Time frame: 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
Time frame: From date of arrhythmia diagnosis or date of treatment start to 30 days of life
Average gestational age at birth
Time frame: At birth
Birth weight (z-scores; centiles)
Time frame: At birth
Total days of treatment related maternal and neonatal hospitalizations
Time frame: From date of diagnosis or treatment begin to 30 days of life
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Time frame: Diagnosis to birth
Maternal prevalence of adverse events and outcome
Time frame: From date of treatment begin to 30 days of life
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2025.
- Individual participant dataSharing planned: No
Related trials for Atrial Flutter
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
Repeat Ablation of Persistent Atrial Fibrillation, Including Mitral Isthmus Catheter Ablation, With the FARAPULSE Pulsed Field Ablation System
Persistent Atrial Fibrillation
Recruiting
Anatomical Navigation for Guided Electrophysiology in AFL and AFib
Atrial Fibrillation, Atrial Flutter
Recruiting
Pericardiotomy in Cardiac Surgery
Atrial Fibrillation, Atrial Flutter
Recruiting
Atrial Flutter Ablation in the iCMR
Atrial Flutter Typical
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edgar Jaeggi, MD, FRCPC principal investigator
The Hospital for Sick Children, Toronto, ON, Canada
41 sites in 14 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atrial Flutter and Tachycardia, Supraventricular, run by Edgar Jaeggi at 41 sites in 14 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in United States, Canada, Sweden, Spain, United Kingdom and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of live-born children with a delivery at term and a normal cardiac rhythm (time frame: Term: 37 0/7 to 41 6/7 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2025.