Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial

Recruiting

• Conditions: Fetal Arrhythmias; rhythm disturbance of the unborn child; 10007521; 10016849

• Registration Number: NL-OMON47515
• Lead Sponsor: Hospital for Sick Children

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

* Diagnosis: Fetal AF without hydrops or SVT without hydrops or SVT with hydrops.
* Tachyarrhythmia significant enough to justify immediate transplacental pharmacological treatment.
Maternal conditions:
* Gestational age <36 0/7 weeks at time of enrolment.
* Untreated at time of enrolment.
* Singleton pregnancy.
* Healthy mother with normal pre-treatment cardiovascular findings.
* Mother capable to make her own health decisions and to understand and follow medical instruction.

Exclusion Criteria

* Fetal AF with hydrops.
* Any maternal-fetal conditions associated with high odds of premature delivery and/or death.
Maternal conditions:
* Any relevant preexisting heart condition.
* Relevant preexisting obstructive airway disease including asthma.
* History of chronic substance abuse.
* Intake of QT-prolonging medication.
* Serum potassium level <3.3 mEq/L.
* Ionized serum calcium level of <1 mmol/l.
* Serum creatinine level >1.1mg/dl.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Term delivery (at least 37 weeks) with a normal cardiac rhythm.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>*Proportion of patients with cardioversion over time.<br /><br>* Proportion of patients with treatment failure:<br /><br>- Fetal demise<br /><br>- Cross-over to 2nd and/or 3rd line therapy<br /><br>- Progression to fetal hydrops (SVT or AF/no hydrops)<br /><br>- Recurrence of SVA on maintenance therapy<br /><br>- Delivery without SVA termination<br /><br>*Proportion, timing and cause of death prior to 1 month corrected age.<br /><br>*Proportion of other events: periventricular leucomalacia and bleeds; NEC;<br /><br>respiratory distress.<br /><br>*Average gestational age at birth and birth weight z-scores.<br /><br>*Average days of maternal and neonatal hospitalization related to SVA therapy.<br /><br>*Maternal prevalence of pregnancy/treatment-related AEs (including caesarean<br /><br>section)</p><br>