NCT04234659

PPCM Observational Study (Peripartum Cardiomyopathy)

Observational Study for Outcomes for Participants With Cardiogenic Shock and Peripartum Cardiomyopathy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 150 (actual)
• Sponsor: Medical College of Wisconsin · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Peripartum Cardiomyopathy
• Cardiogenic Shock

Interventions

Type	Name	Description
DEVICE	Clinical placement of a temporary IMPELLA® mechanical circulatory support device.	Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.

Timeline

• Start date: 2021-01-11
• Primary completion: 2025-08-05
• Completion: 2025-08-05
• First posted: 2020-01-21
• Last updated: 2026-02-23

Locations

1 site across 1 country: United States