Condition: AVB - Atrioventricular Block · Fetal AVB · Sponsor: NYU Langone Health
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 surveill…
This description comes directly from the study's public registry record.
Mala Masson · 212-263-0372 · mala.masson@nyulangone.org
Jill Buyon, MD · 212-263-0756 · Jill.Buyon@nyulangone.org,
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| Phoenix Children's Hospital/Dignity Health | Phoenix, Arizona, United States | Recruiting |
| University of California - Los Angeles (UCLA) | Los Angeles, California, United States | Recruiting |
| Stanford University | Palo Alto, California, United States | Recruiting |
| University of California-San Francisco | San Francisco, California, United States | Recruiting |
| University of Colorado, Denver (UCD) | Aurora, Colorado, United States | Recruiting |
| Yale University School of Medicine | New Haven, Connecticut, United States | Recruiting |
| Children's National Medical Center/George Washington University | Washington D.C., District of Columbia, United States | Recruiting |
| University of Kentucky / Kentucky Children's Hospital | Lexington, Kentucky, United States | Recruiting |
| University of Louisville / Norton Children's Hospital | Louisville, Kentucky, United States | Not Yet Recruiting |
| University of Michigan / C. S. Mott Children's Hospital | Ann Arbor, Michigan, United States | Recruiting |
| Children's Hospital of Minnesota | Minneapolis, Minnesota, United States | Recruiting |
| Perinatal Associates of New Mexico | Rio Rancho, New Mexico, United States | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04474223