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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TERMINATED
365 participants
OBSERVATIONAL
2014-12-31
2023-01-31
Brief Summary
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Detailed Description
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It is anticipated that THEME Registry™ analysis will provide insight into disease defining characteristics resulting in the clinical decision to use the TandemHeart or LifeSPARC System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal. The progression of the illness prior to, during and following support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the patient including strategies used to wean and remove the device. Specifically the objectives of the THEME Registry are:
* Summarize the characteristics of the patients who receive the System for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, exit strategy.
* Evaluate the timing of initiation of System support in relation to the progression of the presenting illness and the association of this with clinical outcomes.
* Collect descriptive data related to clinical management of the patient while on mechanical support, including procedural details, duration of support, anticoagulation, hemodynamics and biochemical parameters to define trends in clinical care and the association of this decision-making with clinical outcomes.
* Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).
* Collect survival and exit strategy status at 30 and 180 days post-initial System insertion.
* Collect serious adverse events from the time of Pump insertion through removal of the System (or Pump).
* Provide data regarding patient characteristics and outcomes.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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TandemHeart or LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC System
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age \>= 18
3. Patient (or legally authorized representative \[LAR\]) has signed informed consent
Exclusion Criteria
2. Participation in a clinical trial of an investigational drug or device
18 Years
ALL
No
Sponsors
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CardiacAssist, Inc.
INDUSTRY
Responsible Party
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Locations
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Princeton-Baptist Medical Center
Birmingham, Alabama, United States
Banner - University Medical Center Tucson
Tucson, Arizona, United States
University of California, San Diego
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
St. John's Hospital
Springfield, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
University of Michigan Health System
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
St. Louis University Hospital
St Louis, Missouri, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University Hospital
Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
University of Virginia Health System
Charlottesville, Virginia, United States
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, United States
Medical College of Wisconsin-Froedtert Hospital
Milwaukee, Wisconsin, United States
Countries
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References
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Rao P, Mosier J, Malo J, Dotson V, Mogan C, Smith R, Keller R, Slepian M, Khalpey Z. Peripheral VA-ECMO with direct biventricular decompression for refractory cardiogenic shock. Perfusion. 2018 Sep;33(6):493-495. doi: 10.1177/0267659118761558. Epub 2018 Feb 21.
Other Identifiers
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THEME
Identifier Type: -
Identifier Source: org_study_id
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