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NCT02624765 · ClinicalTrials.gov registry record · Phase 3
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)
A Phase 3 study of Fetal Atrial Flutter Without Hydrops and Fetal Supraventricular Tachycardia Without Hydrops, sponsored by Edgar Jaeggi.
- Completed
- Registry status
- Phase 3
- Development phase
- 105
- Enrollment target
- 20
- Study locations
NCT02624765 is a Phase 3 study of Fetal Atrial Flutter Without Hydrops and Fetal Supraventricular Tachycardia Without Hydrops that has completed, run by Edgar Jaeggi. The registered enrollment target is 105 participants. The trial reports 20 study locations across 16 states.
The verdict
NCT02624765, a Phase 3 study of Fetal Atrial Flutter Without Hydrops and Fetal Supraventricular Tachycardia Without Hydrops, has completed, sponsored by Edgar Jaeggi.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 105 participants
- Enrollment target
- 20
- Study locations
Study Summary
The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that examines the efficacy and safety of standard prenatal antiarrhythmic treatment. Study components of FAST include three prospective sub-studies to determine the efficacy and safety of commonly used transplacental drug regimens in suppressing fetal AF without hydrops (Randomized Clinical Trial (RCT) A), SVT without hydrops (RCT B), and SVT with hydrops (RCT C). All RCTs are open label phase III trials of standard 1st line therapy, which either is started as monotherapy (no hydrops) or as dual therapy (hydrops).
Conditions Studied
Interventions
- DRUG Digoxin (monotherapy)
- DRUG Sotalol (monotherapy)
- DRUG Flecainide (monotherapy)
- DRUG Digoxin (dual therapy)
- DRUG Sotalol (dual therapy)
Study Locations (20)
New York
- Morgan Stanley Children's Hospital of New York-Presbyterian - New York
- Cohen Children's Medical Center - New York
Texas
- Pediatrix Medical Services, Inc, - Austin
- Baylor College of Medicine - Houston
Ontario
- Mount Sinai Hospital - Toronto
- The Hospital for Sick Children - Toronto
Other
- UKB Universitätsklinikum BONN - Bonn
- Academic Medical Center - AMC - Amsterdam
California
- UCSF Benioff Children's Hospital - San Francisco
Colorado
- Children's Hospital of Colorado - Aurora
District of Columbia
- Children's National Health System - Washington D.C.
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2016-02 |
| Est. Completion | 2024-03-31 |
| Phase | Phase 3 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02624765
The ClinicalTrials.gov registry entry for NCT02624765 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 105 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Edgar Jaeggi, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Fetal Atrial Flutter Without Hydrops appearing as the primary indexed condition, and to 5 interventions - of which Digoxin (monotherapy) is the first listed.
NCT02624765 reports 20 study locations spanning 16 distinct geographic areas - top geographies include New York, Texas, Ontario.
Frequently Asked Questions
What is clinical trial NCT02624765 about?
NCT02624765 is a clinical study titled "Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)". The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that examines the efficacy and safety of standard prenatal antiarrhythmic treatment. Study components of FAST include three prospective sub-studies to determine the efficacy and safety ...
What is the current status of trial NCT02624765?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 105 participants. The study started on 2016-02. Estimated completion is 2024-03-31.
What conditions does trial NCT02624765 study?
This clinical trial studies the following conditions: Fetal Atrial Flutter Without Hydrops, Fetal Supraventricular Tachycardia Without Hydrops, Fetal Supraventricular Tachycardia With Hydrops.
What interventions are being tested in trial NCT02624765?
The interventions under investigation include: Digoxin (monotherapy) (DRUG), Sotalol (monotherapy) (DRUG), Flecainide (monotherapy) (DRUG), Digoxin (dual therapy) (DRUG), Sotalol (dual therapy) (DRUG).
Who is sponsoring clinical trial NCT02624765?
This trial is sponsored by Edgar Jaeggi, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02624765 being conducted?
This trial has 20 study locations across California, Colorado, District of Columbia, New York, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Fetal Atrial Flutter Without Hydrops
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