PPCM Observational Study (Peripartum Ca… | Clinical Trial

Key information

Conditions

Peripartum Cardiomyopathy Cardiogenic Shock Cardiomyopathies Cardiovascular Diseases Female Urogenital Diseases and Pregnancy Complications Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Pregnancy Complications Pregnancy Complications, Cardiovascular Shock Shock, Cardiogenic Urogenital Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Device

Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.

Primary outcomes

Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock.

Time frame: From onset of event through 90 days after participant enrollment.

The retrospective and prospective data collected from study participants will report clinical treatments required to treat the diagnosis of peripartum cardiomyopathy complicated by cardiogenic shock.

Sponsors and collaborators

Lead sponsor

Medical College of Wisconsin

Other

Collaborators

Abiomed Inc.
University of Pennsylvania

Registry information

Official study title

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

Important dates

Study start: 2021
Primary completion: 2025
Study completion: 2025
First posted: Jan 21, 2020
Registry last updated: Feb 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed