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Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)

Primary Purpose

Fetal Atrial Flutter Without Hydrops, Fetal Supraventricular Tachycardia Without Hydrops, Fetal Supraventricular Tachycardia With Hydrops

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Digoxin (monotherapy)
Sotalol (monotherapy)
Flecainide (monotherapy)
Digoxin (dual therapy)
Sotalol (dual therapy)
Flecainide (dual therapy)
Sponsored by
Edgar Jaeggi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fetal Atrial Flutter Without Hydrops focused on measuring RCT A: Fetal Atrial Flutter without Hydrops, RCT B: Fetal Supraventricular Tachycardia without Hydrops, RCT C: Fetal Supraventricular Tachycardia with Hydrops

Eligibility Criteria

16 Years - 50 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mother has provided written informed consent to participate
  2. Either fetal AF without hydrops, SVT without hydrops or SVT with hydrops

  3. Tachyarrhythmia that is significant enough to justify immediate transplacental pharmacological treatment:

    • Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer
    • 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)
  4. Gestational age > 12 0/7 weeks and <36 0/7 weeks at time of enrollment
  5. Untreated tachycardia at time of enrollment
  6. Singleton Pregnancy

  7. 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 branch block allowed)
    • Resting heart rate ≥ 50 bpm
    • Systolic BP ≥ 85 bpm

Exclusion Criteria:

  1. AF with hydrops (eligible for FAST Registry only)
  2. Any maternal-fetal conditions associated with high odds of premature delivery 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)
  3. 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)
  4. Relevant preexisting maternal obstructive airway disease including asthma

  5. Current therapy with the following medications:

    • Antiarrhythmic drugs
    • Pentamidine
  6. Maternal serum potassium level <3.3 mmol/L / <3.3 mEq/L (at start of treatment)
  7. Maternal ionized serum calcium level of <1 mmol/L / <4 mg/dL) or total serum calcium level <2 mmol/L / <8mg/dL (at start of treatment)
  8. Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)

Sites / Locations

  • UCSF Benioff Children's HospitalRecruiting
  • Children's Hospital of ColoradoRecruiting
  • Children's National Health System
  • Morgan Stanley Children's Hospital of New York-PresbyterianRecruiting
  • Cohen Children's Medical CenterRecruiting
  • Cincinnati Children's Hospital Medical CenterRecruiting
  • Vanderbilt University Medical CenterRecruiting
  • Pediatrix Medical Services, Inc,Recruiting
  • Baylor College of MedicineRecruiting
  • University of UtahRecruiting
  • Children's Hospital of Richmond at VCU
  • West Virginia University Research CorporationRecruiting
  • Children's Hospital of WisconsinRecruiting
  • Queensland Children's Hospital
  • The Royal Women's HospitalRecruiting
  • Perth Children's Hospital
  • British Columbia Children's HospitalRecruiting
  • University of Alberta/WCCHNRecruiting
  • CHU Sainte-Justine HospitalRecruiting
  • Mount Sinai HospitalRecruiting
  • The Hospital for Sick ChildrenRecruiting
  • UKB Universitätsklinikum BONNRecruiting
  • Academic Medical Center - AMC
  • Leiden University Medical Center - LUMCRecruiting
  • Erasmus University Medical Center
  • University Medical Center Utrecht
  • Birmingham Women's and Children's NHS Foundation Trust
  • Chelsea and Westminster Hospital NHS Foundation Trust
  • St George's University Hospital Foundation Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

RCT A (1st arm): AF without hydrops

RCT A (2nd arm): AF without hydrops

RCT B (1st arm): SVT without hydrops

RCT B (2nd arm): SVT without hydrops

RCT C (1st arm): SVT with hydrops

RCT C (2nd arm): SVT with hydrops

Arm Description

Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy.

Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy.

Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy.

Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy.

Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol.

Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide.

Outcomes

Primary Outcome Measures

Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).

Secondary Outcome Measures

Proportion of patients with cardioversion over time
Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
Proportion of participants with treatment failure
Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death.
Proportion of participants with arrhythmia-related death
Number of participants with arrhythmia-related death compared to other outcomes
Average gestational age at birth
Mean of the gestational age at birth
Birth weight z-scores
A birth weight z-score compares a child's birth weight to the weight of a child of the same length/height and gender to classify nutritional status
Total days of treatment related maternal and neonatal hospitalizations
Average days of maternal and neonatal hospitalization related to SVA therapy
Maternal prevalence of adverse events and outcome
Maternal prevalence of pregnancy/treatment-related AEs and outcomes

Full Information

First Posted
November 30, 2015
Last Updated
October 12, 2021
Sponsor
Edgar Jaeggi
Collaborators
Canadian Institutes of Health Research (CIHR), St George's, University of London
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1. Study Identification

Unique Protocol Identification Number
NCT02624765
Brief Title
Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)
Official Title
FAST RCT: Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Edgar Jaeggi
Collaborators
Canadian Institutes of Health Research (CIHR), St George's, University of London

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Few studies are specifically designed to address health concerns relevant during pregnancy. The consequence is a lack of evidence on best clinical practice. This includes mothers and their babies when pregnancy is complicated by an abnormally fast heart rate up to 300 beats per minute due to supraventricular tachyarrhythmia (SVA) in the unborn baby (fetus). Although fetal SVA, including atrial flutter (AF) and other forms of supraventricular tachycardia (SVT), is the most common cause of intended in-utero fetal therapy, none of the medication used to date has been evaluated for their effects on the mother and her baby in a randomized controlled trial (RCT). As a consequence, physicians need to make decisions about the management of such pregnancies without any evidence from controlled trials on drug efficacy and safety and no consensus among specialists for the optimal management. The Fetal Atrial Flutter and Supraventricular Tachycardia (FAST) Therapy Trial is a prospective multi-center trial that addresses this knowledge gap to guide future fetal SVA therapy to the best of care. 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 (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). The primary study aim is the probability of a normal pregnancy outcome after treatment start with Digoxin or Sotalol (AF without hydrops); Digoxin or Flecainide (SVT without hydrops); and Digoxin plus Sotalol or Digoxin plus Flecainide (SVT with hydrops).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fetal Atrial Flutter Without Hydrops, Fetal Supraventricular Tachycardia Without Hydrops, Fetal Supraventricular Tachycardia With Hydrops
Keywords
RCT A: Fetal Atrial Flutter without Hydrops, RCT B: Fetal Supraventricular Tachycardia without Hydrops, RCT C: Fetal Supraventricular Tachycardia with Hydrops

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RCT A (1st arm): AF without hydrops
Arm Type
Active Comparator
Arm Description
Atrial Flutter (AF) without hydrops: Treatment with Digoxin as monotherapy.
Arm Title
RCT A (2nd arm): AF without hydrops
Arm Type
Active Comparator
Arm Description
Atrial Flutter (AF) without hydrops: Treatment with Sotalol as monotherapy.
Arm Title
RCT B (1st arm): SVT without hydrops
Arm Type
Active Comparator
Arm Description
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Digoxin as monotherapy.
Arm Title
RCT B (2nd arm): SVT without hydrops
Arm Type
Active Comparator
Arm Description
Supraventricular Tachycardia (SVT) without hydrops: Treatment with Flecainide as monotherapy.
Arm Title
RCT C (1st arm): SVT with hydrops
Arm Type
Active Comparator
Arm Description
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Sotalol.
Arm Title
RCT C (2nd arm): SVT with hydrops
Arm Type
Active Comparator
Arm Description
Supraventricular Tachycardia (SVT) with hydrops: Treatment with Digoxin and Flecainide.
Intervention Type
Drug
Intervention Name(s)
Digoxin (monotherapy)
Intervention Description
Oral or IV loading dose: 0.5 mg q 12 h (total 4 doses over 48 hours) followed by Oral maintenance dose: 0.25 mg-1mg/day
Intervention Type
Drug
Intervention Name(s)
Sotalol (monotherapy)
Intervention Description
Oral dose: 80 mg TID or 120 mg BID (240 mg/day)
Intervention Type
Drug
Intervention Name(s)
Flecainide (monotherapy)
Intervention Description
Oral dose: 100 mg TID (300 mg/day)
Intervention Type
Drug
Intervention Name(s)
Digoxin (dual therapy)
Intervention Description
Oral or IV loading dose: 0.5 mg q 8 h (total 4 doses over 32 hours) followed by oral maintenance dose: 0.25 mg-1mg/day
Intervention Type
Drug
Intervention Name(s)
Sotalol (dual therapy)
Intervention Description
Oral dose: 160 mg BID (320 mg/day)
Intervention Type
Drug
Intervention Name(s)
Flecainide (dual therapy)
Intervention Description
Oral dose:100 mg TID (300 mg/day)
Primary Outcome Measure Information:
Title
Proportion of live-born children with a delivery at term and a normal cardiac rhythm
Description
Term delivery (≥37 0/7 weeks gestation) with a normal cardiac rhythm (ECG).
Time Frame
Term: 37 0/7 to 41 6/7 weeks
Secondary Outcome Measure Information:
Title
Proportion of patients with cardioversion over time
Description
Number of participants with persistent tachycardia compared to number of participants with cardioversion to a normal rhythm over time
Time Frame
From date of randomization 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
Title
Proportion of participants with treatment failure
Description
Number of participants with treatment failure compared to number of participants with successful treatment. Treatment failure is defined as one of the following: 1) cross-over to another drug; 2) SVT/AF that persists to birth; 3) preterm birth; 4) death.
Time Frame
From date of randomization until the date of first documented fetal cardioversion or until the date of treatment failure, whichever comes first, assessed up to 30 gestational weeks
Title
Proportion of participants with arrhythmia-related death
Description
Number of participants with arrhythmia-related death compared to other outcomes
Time Frame
From date of randomization to 30 days of life
Title
Average gestational age at birth
Description
Mean of the gestational age at birth
Time Frame
At birth
Title
Birth weight z-scores
Description
A birth weight z-score compares a child's birth weight to the weight of a child of the same length/height and gender to classify nutritional status
Time Frame
At birth
Title
Total days of treatment related maternal and neonatal hospitalizations
Description
Average days of maternal and neonatal hospitalization related to SVA therapy
Time Frame
From date of randomization to 30 days of life
Title
Maternal prevalence of adverse events and outcome
Description
Maternal prevalence of pregnancy/treatment-related AEs and outcomes
Time Frame
From date of randomization to 30 days of life

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 transplacental pharmacological treatment: Tachycardia ≥ 180 bpm during at least 10% of observation time of 30 minutes or longer 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 branch block allowed) Resting heart rate ≥ 50 bpm Systolic BP ≥ 85 bpm Exclusion Criteria: AF with hydrops (eligible for FAST Registry only) Any maternal-fetal conditions associated with high odds of premature delivery 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) 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 calcium level <2 mmol/L / <8mg/dL (at start of treatment) Maternal serum creatinine level > 97.2 µmol/L (>1.1 mg/dl)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Prachi Sharma, MSc, CCRA
Phone
1-416-813-7654
Ext
309423
Email
fast.trial@sickkids.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Diana Balmer-Minnes, H.BSc CCRP
Phone
1-416-813-7654
Ext
228624
Email
fast.trial@sickkids.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
Organizational Affiliation
The Hospital for Sick Children, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCSF Benioff Children's Hospital
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anita Moon-Grady, MD
First Name & Middle Initial & Last Name & Degree
Anita Moon-Grady, MD
Facility Name
Children's Hospital of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bettina Cuneo, MS
First Name & Middle Initial & Last Name & Degree
Bettina Cuneo, MD
Facility Name
Children's National Health System
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Donofrio, MD
First Name & Middle Initial & Last Name & Degree
Mary Donofrio, MD
Facility Name
Morgan Stanley Children's Hospital of New York-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Levasseur, MD
First Name & Middle Initial & Last Name & Degree
Stephanie Levasseur, MD
Facility Name
Cohen Children's Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
269-01
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elizabeth Mitchell, MD
First Name & Middle Initial & Last Name & Degree
Elizabeth Mitchell, MD
Facility Name
Cincinnati Children's Hospital Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Allison Divanovic, MD
First Name & Middle Initial & Last Name & Degree
Allison Divanovic, MD
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacy Killen, MD
First Name & Middle Initial & Last Name & Degree
Stacy Killen, MD
Facility Name
Pediatrix Medical Services, Inc,
City
Austin
State/Province
Texas
ZIP/Postal Code
78722
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeannine Schuman-McCoy, MD
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shaine Morris, MD
First Name & Middle Initial & Last Name & Degree
Nancy Ayres, MD
First Name & Middle Initial & Last Name & Degree
Shaine Morris, MD
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nelangi Pinto, MD
Facility Name
Children's Hospital of Richmond at VCU
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298-0026
Country
United States
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabrina C Minter
Email
Sabrina.Minter@vcuhealth.org
First Name & Middle Initial & Last Name & Degree
John R Phillips, MD
Facility Name
West Virginia University Research Corporation
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Phil Saul, MD
First Name & Middle Initial & Last Name & Degree
Phil Saul, MD
First Name & Middle Initial & Last Name & Degree
Christopher Mercer, MD
Facility Name
Children's Hospital of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erika Peterson, MD
First Name & Middle Initial & Last Name & Degree
Janette Strasburger, MD
First Name & Middle Initial & Last Name & Degree
Erika Peterson, MD
Facility Name
Queensland Children's Hospital
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
QLD 4101
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr. Ben Auld, MD
Facility Name
The Royal Women's Hospital
City
Melbourne
State/Province
Victoria
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Darren Hutchinson, MD
Facility Name
Perth Children's Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Deane Yim, MD
Facility Name
British Columbia Children's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6H 3N1
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shreya Moodley, MD
First Name & Middle Initial & Last Name & Degree
Shreya Moodley, MD
Facility Name
University of Alberta/WCCHN
City
Edmonton
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lisa Hornberger, MD
Facility Name
CHU Sainte-Justine Hospital
City
Montreal
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marie-Josee Raboisson, MD
Facility Name
Mount Sinai Hospital
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Greg Ryan, MD
Facility Name
The Hospital for Sick Children
City
Toronto
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
Phone
416-813-7500
Email
edgar.jaeggi@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Prachi Sharma, M.Sc
Phone
416-813-7654
Ext
309423
Email
prachi.sharma@sickkids.ca
First Name & Middle Initial & Last Name & Degree
Edgar Jaeggi, MD
Facility Name
UKB Universitätsklinikum BONN
City
Bonn
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ulrike Herberg, MD
First Name & Middle Initial & Last Name & Degree
Ulrich Gembruch, Prof
Facility Name
Academic Medical Center - AMC
City
Amsterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nico Blom, MD
Facility Name
Leiden University Medical Center - LUMC
City
Leiden
Country
Netherlands
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nico Blom, MD
Facility Name
Erasmus University Medical Center
City
Rotterdam
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
I Beijnum, MD
Facility Name
University Medical Center Utrecht
City
Utrecht
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TJ Steenhuis, MD
Facility Name
Birmingham Women's and Children's NHS Foundation Trust
City
Birmingham
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
Chelsea and Westminster Hospital NHS Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Active, not recruiting
Facility Name
St George's University Hospital Foundation Trust
City
London
Country
United Kingdom
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Learn more about this trial

Prospective Randomized Clinical Trial of Fetal Atrial Flutter & Supraventricular Tachycardia Therapy (FAST RCT)

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