Phase
Condition
Fast Heart Rate (Tachycardia)
Atrial Flutter
Atrial Fibrillation
Treatment
Flecainide (dual therapy)
Digoxin (dual therapy)
Digoxin (monotherapy)
Clinical Study ID
Ages 16-50 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Mother has provided written informed consent to participate
Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops
Tachyarrhythmia that is significant enough to justify immediate transplacentalpharmacological treatment:
Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes orlonger
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)
Gestational age > 12 0/7 weeks and <36 0/7 weeks at time of enrollment
Untreated tachycardia at time of enrollment
Singleton Pregnancy
Healthy mother with ± normal pre-treatment cardiovascular findings:
ECG without significant abnormalities (sinus rhythm; QTc ≤ 0.47; PR ≤ 0.2 sec;QRS: ≤ 0.12 sec; isolated PACs or PVCs or isolated complete right bundle branchblock allowed)
Resting heart rate ≥ 50 bpm
Systolic BP ≥ 85 bpm
Exclusion
Exclusion Criteria:
AF with hydrops (eligible for FAST Registry only)
Any maternal-fetal conditions associated with high odds of premature delivery ordeath other than tachycardia (e.g. severe IUGR; premature rupture of membrane;life-threatening maternal disease (incl. pre-eclampsia; HELLP syndrome); severecongenital fetal abnormalities (T 13 or 18; surgery or death expected < 1 month)
History of significant maternal heart condition (open heart surgery; sick sinussyndrome; channelopathy (long QT, Brugada syndrome); ventricular tachycardia; WPWsyndrome; high-degree heart block; cardiomyopathy)
Relevant preexisting maternal obstructive airway disease including asthma
Current therapy with the following medications:
Antiarrhythmic drugs
Pentamidine
Maternal serum potassium level <3.3 mmol/L / <3.3 mEq/L (at start of treatment)
Maternal ionized serum calcium level of <1 mmol/L / <4 mg/dL) or total serum calciumlevel <2 mmol/L / <8mg/dL (at start of treatment)
Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)
Study Design
Study Description
Connect with a study center
Queensland Children's Hospital
South Brisbane, Queensland QLD 4101
AustraliaSite Not Available
The Royal Women's Hospital
Melbourne, Victoria
AustraliaSite Not Available
Perth Children's Hospital
Nedlands, Western Australia 6009
AustraliaSite Not Available
University of Alberta/WCCHN
Edmonton, Alberta
CanadaSite Not Available
British Columbia Children's Hospital
Vancouver, British Columbia V6H 3N1
CanadaSite Not Available
Mount Sinai Hospital
Toronto, Ontario
CanadaSite Not Available
The Hospital for Sick Children
Toronto, Ontario
CanadaSite Not Available
CHU Sainte-Justine Hospital
Montreal, Quebec
CanadaSite Not Available
Alberta Children's Hospital
Calgary,
CanadaSite Not Available
McMaster University
Hamilton,
CanadaSite Not Available
Children's Hospital of Eastern Ontario
Ottawa,
CanadaSite Not Available
UKB Universitätsklinikum BONN
Bonn,
GermanySite Not Available
Academic Medical Center - AMC
Amsterdam,
NetherlandsSite Not Available
Leiden University Medical Center - LUMC
Leiden,
NetherlandsSite Not Available
Erasmus University Medical Center
Rotterdam,
NetherlandsSite Not Available
University Medical Center Utrecht
Utrecht,
NetherlandsSite Not Available
Belfast Health and Social Care Trust
Belfast,
United KingdomSite Not Available
Belfast Health and Social Care Trust
Belfast, Northern Ireland,
United KingdomSite Not Available
Birmingham Women's and Children's NHS Foundation Trust
Birmingham,
United KingdomSite Not Available
University Hospital Bristol
Bristol,
United KingdomSite Not Available
The Ian Donald Centre for Foetal Medicine, Southern General Hospital
Glasgow,
United KingdomSite Not Available
Liverpool Women's Hospital
Liverpool,
United KingdomSite Not Available
Chelsea and Westminster Hospital NHS Foundation Trust
London,
United KingdomSite Not Available
St George's University Hospital Foundation Trust
London,
United KingdomSite Not Available
University Hospital Southampton
Southampton,
United KingdomSite Not Available
Ronald Reagan UCLA Medical Center
Los Angeles, California
United StatesSite Not Available
UCSF Benioff Children's Hospital
San Francisco, California 94158
United StatesSite Not Available
Children's Hospital of Colorado
Aurora, Colorado 80045
United StatesSite Not Available
Children's Hospital of Colorado
Denver, Colorado
United StatesSite Not Available
Children's National Health System
Washington, District of Columbia 20010
United StatesSite Not Available
Boston Childrens Hospital
Boston, Massachusetts
United StatesSite Not Available
Cohen Children's Medical Center
New York, New York 269-01
United StatesSite Not Available
Morgan Stanley Children's Hospital of New York-Presbyterian
New York, New York 10032
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesSite Not Available
MUSC Children's Hospital
Charleston, South Carolina
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37232
United StatesSite Not Available
Pediatrix Medical Services, Inc,
Austin, Texas 78722
United StatesSite Not Available
Baylor College of Medicine
Houston, Texas 77030
United StatesSite Not Available
University of Utah
Salt Lake City, Utah 84112
United StatesSite Not Available
Children's Hospital of Richmond at VCU
Richmond, Virginia 23298-0026
United StatesSite Not Available
West Virginia University Research Corporation
Morgantown, West Virginia 26506
United StatesSite Not Available
Children's Hospital of Wisconsin
Milwaukee, Wisconsin 53226
United StatesSite Not Available
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