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

Recruiting Phase 3 Interventional Study
AVB - Atrioventricular Block Fetal AVB
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,300 (estimated)
Sponsor
NYU Langone Health · Other
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About This Trial
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 limi…
Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Provision of signed and dated informed consent form 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Be \<18 weeks pregnant at the time of enrollment 4. Titer of anti-Ro 52 or 60 antibodies ≥1,000 EU 5. Any positive t…
Contacts

Mala Masson

212-263-0372

mala.masson@nyulangone.org

CONTACT

Jill Buyon, MD

212-263-0756

Jill.Buyon@nyulangone.org,

CONTACT