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Trial ID CV027-014  |   NCT05939700

Mavacamten Pregnancy Surveillance Program

Summary

  • Female Gender icon
  • 15+
    Age Range
  • 1
    Locations
  • BMS Recruiting Study icon
    Recruiting

Overview

The purpose of this observational pregnancy safety study is to assess maternal, fetal, and infant outcomes after exposure to mavacamten at any time during pregnancy and/or breastfeeding.

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Key Eligibility Criteria

Inclusion Criteria: - Exposure to at least 1 dose of mavacamten at any time during pregnancy (from 4 months prior to conception to pregnancy outcome) and/or at any time during breastfeeding (up to 12 months of infant age or weaning, whichever comes first) - At least 15 years of age or older at the time of enrollment - Informed consent or institutional review board/ethics committee-approved waiver of informed consent Exclusion Criteria: - None

Treatment Options

Study Arms

ASSIGNED INTERVENTION

Study Arms

Cohort 1

ASSIGNED INTERVENTION
  • Drug: Mavacamten
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