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Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia (FAST Registry)

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ClinicalTrials.gov Identifier: NCT03376438
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : August 16, 2021
Sponsor:
Collaborator:
Labatt Family Heart Centre
Information provided by (Responsible Party):
Edgar Jaeggi, The Hospital for Sick Children

Tracking Information
First Submitted Date September 27, 2017
First Posted Date December 18, 2017
Last Update Posted Date August 16, 2021
Actual Study Start Date June 8, 2017
Estimated Primary Completion Date May 31, 2027   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 15, 2017)
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 ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: December 15, 2017)
  • 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 ]
    Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
  • 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 ]
    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.
  • Proportion of participants with arrhythmia-related death [ Time Frame: From date of arrhythmia diagnosis or date of treatment start to 30 days of life ]
    Number of participants with arrhythmia-related death compared to other outcomes
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition
  • Atrial Flutter
  • Tachycardia, Supraventricular
  • Tachycardia, Atrial Ectopic
  • Tachycardia, Reciprocating
  • Tachycardia Atrial
  • Tachycardia, Atrioventricular Nodal Reentry
  • Tachycardia, Paroxysmal
  • Fetal Hydrops
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.
Other Name: Non-randomized antiarrhythmic fetal drug therapy
Study Groups/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
Intervention: Other: Prospective observational cohorts
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: December 15, 2017)
1000
Original Estimated Enrollment Same as current
Estimated Study Completion Date May 31, 2027
Estimated Primary Completion Date May 31, 2027   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Ages 16 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Diana Balmer-Minnes, BSc, CCRP 416-813-7654 ext 228624 FAST.Trial@sickkids.ca
Contact: Prachi Sharma, MSc, CCRA 416-813-7654 ext 309423 FAST.Trial@sickkids.ca
Listed Location Countries Australia,   Brazil,   Canada,   Czechia,   Finland,   France,   Hong Kong,   Netherlands,   Russian Federation,   Spain,   Sweden,   Switzerland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03376438
Other Study ID Numbers 1000048953
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Edgar Jaeggi, The Hospital for Sick Children
Study Sponsor The Hospital for Sick Children
Collaborators Labatt Family Heart Centre
Investigators
Principal Investigator: Edgar Jaeggi, MD, FRCPC The Hospital for Sick Children, Toronto, ON, Canada
PRS Account The Hospital for Sick Children
Verification Date August 2021