Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
10 participants
OBSERVATIONAL
2021-01-11
2023-02-01
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Individuals Receiving Mechanical Circulatory Device Support
Individuals receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.
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.
Individuals Without Mechanical Circulatory Device Support
Individuals not receiving mechanical circulatory support device (specifically the IMPELLA® device) for treatment of their index peripartum cardiomyopathy complicated by cardiogenic shock event.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* inability of participant to provide informed consent
18 Years
FEMALE
No
Sponsors
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Abiomed Inc.
INDUSTRY
University of Pennsylvania
OTHER
Medical College of Wisconsin
OTHER
Responsible Party
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Sarah Thordsen
Assistant Professor Cardiovascular Medicine
Principal Investigators
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Sarah Thordsen, MD
Role: PRINCIPAL_INVESTIGATOR
Medical College of Wisconsin
Locations
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Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Central Contacts
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Facility Contacts
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Mary C Wexler, BS
Role: primary
References
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McNamara DM, Elkayam U, Alharethi R, Damp J, Hsich E, Ewald G, Modi K, Alexis JD, Ramani GV, Semigran MJ, Haythe J, Markham DW, Marek J, Gorcsan J 3rd, Wu WC, Lin Y, Halder I, Pisarcik J, Cooper LT, Fett JD; IPAC Investigators. Clinical Outcomes for Peripartum Cardiomyopathy in North America: Results of the IPAC Study (Investigations of Pregnancy-Associated Cardiomyopathy). J Am Coll Cardiol. 2015 Aug 25;66(8):905-14. doi: 10.1016/j.jacc.2015.06.1309.
Kolte D, Khera S, Aronow WS, Palaniswamy C, Mujib M, Ahn C, Jain D, Gass A, Ahmed A, Panza JA, Fonarow GC. Temporal trends in incidence and outcomes of peripartum cardiomyopathy in the United States: a nationwide population-based study. J Am Heart Assoc. 2014 Jun 4;3(3):e001056. doi: 10.1161/JAHA.114.001056.
Doerr M, Grayson S, Moore S, Suver C, Wilbanks J, Wagner J. Implementing a universal informed consent process for the All of Us Research Program. Pac Symp Biocomput. 2019;24:427-438.
Other Identifiers
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PRO35709
Identifier Type: -
Identifier Source: org_study_id