PPCM Observational Study (Peripartum Cardiomyopathy)

Medical College of Wisconsin

Status: Unknown

Conditions: Peripartum Cardiomyopathy; Cardiogenic Shock

Treatments: Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04234659

PRO35709

Details and patient eligibility

About

The purpose of this study is to examine the clinical treatment of patients diagnosed with peripartum cardiomyopathy complicated by cardiogenic shock.

Full description

This single-site, virtual, longitudinal, observational study will investigate two cohorts (study groups) by enrolling a total of ten participants, five in each cohort. The two cohorts include individuals who received mechanical circulatory support (specifically the IMPELLA® device) compared to individuals who did not receive mechanical circulatory support for treatment of their PPCM complicated by cardiogenic shock index event.

The duration of enrollment for each participant is about 5 months. It is anticipated that the trial will be complete in 12 months. Participant engagement to the study will be self-initiated.

Under the guidance and support of Medical College of Wisconsin research coordinator, participants will directly access the study REDCapTM database for enrollment and follow-up data entry for this study. The research coordinator will obtain and abstract participant medical records documenting the event.

Enrollment: 10 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Females:

• age ≥ 18 years old at the time of entry into the study
• who have capacity to provide consent for study participation
• with self-reported PPCM complicated by cardiogenic shock
• individuals should have US citizenship
• index event occurring within the continental United States.

Exclusion criteria

• lack of medical records supporting pregnancy, peripartum cardiomyopathy or cardiogenic shock by study definition
• inability of participant to provide informed consent

Trial design

10 participants in 2 patient groups

Individuals Receiving Mechanical Circulatory Device Support

Description:

Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.

Treatment:

Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.

Individuals Without Mechanical Circulatory Device Support

Description:

Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.