PPCM Observational Study (Peripartum Cardiomyopathy)

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

Detailed Description
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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.

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

Conditions
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Peripartum Cardiomyopathy, Cardiogenic Shock

Intervention / Treatment
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* Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Individuals Receiving Mechanical Circulatory Device Support<br>Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event. | Device: Clinical placement of a temporary IMPELLA® mechanical circulatory support device.<br>* Surgical placement of the IMPELLA® device for life threatening cardiogenic shock not responsive to other medical treatment.<br>|
| Individuals Without Mechanical Circulatory Device Support<br>Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of the Long-term Clinical Course of Patients with Peripartum Cardiomyopathy complicated by cardiogenic shock. | 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. | From onset of event through 90 days after participant enrollment. |