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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Pregnant or breastfeeding women exposed to mavacamten |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mavacamten | Drug | Observational study of individuals exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pregnancy outcomes | (1) Number of live births, full term or preterm births, stillbirths, spontaneous abortions, and elective abortions, (2) Number of participants with pregnancy complications | Up to 10 months |
| Fetal/neonatal/infant outcomes | Number of fetal/neonatal/infants in utero, at birth, and through the first year of life with major and minor congenital malformations, small for gestational age, premature delivery, and post-natal growth and development deficiency | Up to 12 months post pregnancy outcome |
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Inclusion Criteria:
Exclusion Criteria:
- None
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Individuals 15 years of age or older who are exposed to at least 1 dose of mavacamten at any time during pregnancy and/or breastfeeding.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Study Connect Contact Center www.BMSStudyConnect.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol-Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Mavacamten Pregnancy Surveillance Program, PPD Inc | Recruiting | Wilmington | North Carolina | 28401-3331 | United States |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| Investigator Inquiry Form | View source |
| FDA Safety Alerts and Recalls |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| D002312 | Cardiomyopathy, Hypertrophic |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
| D009202 | Cardiomyopathies |
| D006331 | Heart Diseases |
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| ID | Term |
|---|---|
| C000605992 | MYK-461 |
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| D002318 |
| Cardiovascular Diseases |
| D001020 | Aortic Stenosis, Subvalvular |
| D001024 | Aortic Valve Stenosis |
| D000082862 | Aortic Valve Disease |
| D006349 | Heart Valve Diseases |