Fetal Atrial Flutter & Supraventricular Tachycardia (FAST) Therapy Trial - FAST

The Hospital for Sick Children0 个研究点目标入组 105 人开始时间: 2019年4月17日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

•Mother has provided written informed consent to participate in the RCT
•Mother aged =18 years at time of enrolment
•Fetal AF without hydrops (RCT A) or SVT without hydrops (RCT B) or SVT with hydrops (RCT C)
•Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:
•- Tachycardia = 170 bpm during +100% of time (= 30 0/7 weeks of gestation)
•- Tachycardia = 180 bpm during at least 10% of observation time
•- Tachycardia = 280 bpm
•- Tachycardia with fetal hydrops
•Gestational age = 12 0/7 weeks and <36 0/7 weeks at time of enrolment
•Untreated arrhythmia at time of enrolment
•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 branch block;non-specific ST-T segment changes allowed)
•- Maternal resting heart rate = 50 bpm
•- Maternal Systolic BP = 85 mm Hg

•Fetal AF with hydrops (condition is too infrequent to be studied in a separate RCT sub-study; eligible for Registry)
•Any maternal-fetal conditions associated with high odds of premature delivery and/or death other than tachycardia (e.g. severe IUGR; premature rupture of membrane; life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severe congenital fetal abnormalities (T 13 or 18; surgery or death expected < 1 month))
•History of significant maternal heart condition (open heart surgery; sick sinus syndrome; channelopathy (long QT, Brugada syndrome); ventricular tachycardia; WPW syndrome; high-degree heart block; cardiomyopathy)
•History of significant maternal obstructive airway disease including asthma
•Maternal serum potassium level < 3.3mmol/L / <3.3 mEq/L
•Maternal ionized serum calcium level of <1 mmol/L / <4mg/dL or total serum calcium level <2mmol/L / < 8mg/dL
•Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)
•Maternal intake of QT-prolonging medication including but not limited to the following medications: http://www.crediblemeds.org/pdftemp/pdf/CompositeList.pdf

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