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Clinical trialNCT04474223RecruitingPhase 3Interventional

Surveillance and Treatment to Prevent Fetal Atrioventricular Block Likely to Occur Quickly (STOP BLOQ)

SponsorNYU Langone HealthEnrollment1,300AVB - Atrioventricular BlockFetal AVB
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Fetal complete (i.e., third degree, 3°) atrioventricular block (AVB), identified in the 2nd trimester of pregnancy in an otherwise normally developing heart, is almost universally associated with maternal anti-Ro autoantibodies and results in death in a fifth of cases. To date treatment of 3° AVB has been ineffective in restoring normal rhythm (NR) which may be because current surveillance is limited to once- weekly fetal echocardiograms. It is hypothesized that there may be a vital transition period of several hours in which incomplete block (2° AVB) may be successfully treated avoiding fully advanced irreversible 3° AVB. To optimize the likelihood of timely detection of the transition period this study comprises three steps: 1) to risk stratify for high titer anti-Ro antibodies, which are necessary but not sufficient to develop fetal AVB; 2) to empower mothers to identify 2° AVB by using fetal heart rate and rhythm monitoring (FHRM) at home, and 3) to rapidly treat mothers who detect an abnormality by monitoring with an urgent echocardiogram that confirms 2° AVB with the hope of reversing 2° AVB before it becomes permanent (3° AVB). In addition, it will be determined if FHRM reduces the need for weekly echoes. Although mothers with low titer anti-Ro will not be continued in Step 2 and therefore not followed by FHRM, birth ECGs will be collected to confirm that low titer antibodies do not confer risk. It is anticipated that this study will provide an evidenced based surveillance strategy for those mothers at high risk of having a child with 3° AVB.

Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

24 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

Canada
  • Stollery Children'S Hospital

    Edmonton, Alberta, Canada

    Lisa Hornberger, MD
    Not, yet, recruiting
United States
  • Phoenix Children'S Hospital/dignity Health

    Phoenix, Arizona, United States

    Christopher Lindblade, MD
    Recruiting
  • University of California - Los Angeles (ucla)

    Los Angeles, California, United States

    D Krakow, MDGary Satou, MDMark Sklansky, MD
    Recruiting
  • Stanford University

    Palo Alto, California, United States

    Michelle Kaplinski, MDTheresa Tacy, MD
    Recruiting
  • University of California-San Francisco

    San Francisco, California, United States

    Anita Mood-Grady, MD
    Recruiting
  • University of Colorado, Denver (ucd)

    Aurora, Colorado, United States

    Bettina Cuneo, MD
    Recruiting
  • Yale University School of Medicine

    New Haven, Connecticut, United States

    Joshua Copel, MD
    Recruiting
  • Children'S National Medical Center/george Washington University

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

    Anita Krishnan, MDMary Donofrio, MD
    Recruiting
  • University of Kentucky / Kentucky Children'S Hospital

    Lexington, Kentucky, United States

    Kristopher Cumbermack, MD
    Recruiting
  • University of Louisville / Norton Children'S Hospital

    Louisville, Kentucky, United States

    Brian Holland, MDJyothi Matta, MBBS
    Not, yet, recruiting
  • University of Michigan / C. S. Mott Children'S Hospital

    Ann Arbor, Michigan, United States

    Jimmy Lu, MDSonal Owens, MD
    Recruiting
  • Children'S Hospital of Minnesota

    Minneapolis, Minnesota, United States

    Lisa Howley, MD
    Recruiting
  • Perinatal Associates of New Mexico

    Rio Rancho, New Mexico, United States

    Gary Joffe, MD
    Recruiting
  • Columbia University Medical Center

    New York, New York, United States

    Stephanie Levasseur, MD
    Recruiting
  • Mount Sinai

    New York, New York, United States

    Erin Paul, MD
    Recruiting
  • Nyu Langone Health

    New York, New York, United States

    Colin Phoon, MDJill Buyon, MD →
    Recruiting
  • Cleveland Clinic Lerner College of Medicine

    Cleveland, Ohio, United States

    Rukmini Komarlu, MD
    Recruiting
  • Uh Rainbow Babies / Children'S Hospital

    Cleveland, Ohio, United States

    James Strainic, MD
    Recruiting
  • Vanderbilt University Medical Center

    Nashville, Tennessee, United States

    Stacy Stratemann-Killen, MD
    Recruiting
  • Baylor College of Medicine

    Houston, Texas, United States

    Shreya Sheth, MDTam Doan, MD
    Recruiting
  • University of Utah Health

    Salt Lake City, Utah, United States

    Whitnee Hogan, MD
    Recruiting
  • University of Vermont Children'S Hospital

    Burlington, Vermont, United States

    Caitlin Haxel, MD
    Recruiting
  • Eastern Virginia Medical School (evms)

    Norfolk, Virginia, United States

    Alfred Abuhamad, MDElena Sinkovskaya, MD
    Recruiting
  • Seattle Children'S Hospital

    Seattle, Washington, United States

    Bhawna Arya, MD
    Not, yet, recruiting

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
1 Aug 2020
Primary completion
31 Dec 2028
Completion
30 Jun 2029
Last update posted
6 Apr 2026
Registered enrollment
1,300
Registry id
NCT04474223

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.