Trials Sponsors Conditions Drugs Pricing

Conditions

Atrial Flutter Fetal Hydrops Tachycardia Atrial Tachycardia, Atrial Ectopic Tachycardia, Atrioventricular Nodal Reentry Tachycardia, Paroxysmal Tachycardia, Reciprocating Tachycardia, Supraventricular

Outcome Measures

Primary Outcomes (1)

Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Term: 37 0/7 to 41 6/7 weeks

Secondary Outcomes (8)

Proportion of patients with cardioversion over time
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
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

Study Arms (1)

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

Other: Prospective observational cohorts

Interventions

Prospective observational cohortsOther

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.

Also known as: Non-randomized antiarrhythmic fetal drug therapy

Prospective observational cohorts

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age16 Years - 50 Years

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64)

Sampling MethodProbability 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.

You may qualify if:

Sponsors & Collaborators

Edgar Jaeggi
Otherlead

Study Sites (41)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

University of California, San Francisco

San Francisco, California, 94158, United States

Children's Hospital Colorado

Denver, Colorado, 80205, United States

Children's National Medical Center

Washington D.C., District of Columbia, 20010, United States

Johns Hopkins All Children's Hospital

Saint Petersberg, Florida, 33701-4804, United States

John Ochsner Heart & Vascular Institute

New Orleans, Louisiana, 70121, United States

Boston Children's Hospital

MeSH Terms

Conditions

Atrial FlutterTachycardia, SupraventricularTachycardia, Ectopic AtrialTachycardia, ReciprocatingTachycardia, Atrioventricular Nodal ReentryTachycardia, ParoxysmalHydrops Fetalis

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsTachycardiaCardiac Conduction System DiseaseErythroblastosis, Fetal

Study Officials

Edgar Jaeggi, MD, FRCPC
The Hospital for Sick Children, Toronto, ON, Canada
PRINCIPAL INVESTIGATOR

Enrollment

330 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: OTHER
Responsible Party: SPONSOR INVESTIGATOR
PI Title: Senior Associate Scientist Emeritus Edgar Jaeggi, MD FRCPC

Study Record Dates

First Submitted

September 27, 2017

First Posted

December 18, 2017

Study Start

June 8, 2017

Actual (reported)

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

Prospective observational cohorts

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Prospective Observational Cohort Study of Fetal Atrial Flutter & Supraventricular Tachycardia

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (1)

Prospective observational cohorts

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (41)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations