TandemHeart Experiences and MEthods (THEME Registry)
Stopped early
Conditions studied: Heart Diseases, Lung Diseases
In brief
This study is intended to be a multicenter, prospective observation registry. By collecting prospective descriptive data, provide insight into disease defining characteristics resulting in the clinical decision to use TandemHeart® or LifeSPARC™ System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.
Key facts
- Study ID
- NCT02326402
- Run by
- CardiacAssist, Inc.
- People needed
- 365
- Starts
- 2014-12-01
- Expected to finish
- 2023-01-01
- Last updated by the study team
- 2023-09-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
- Age >= 18
- Patient (or legally authorized representative [LAR]) has signed informed consent
You may not qualify if…
- Patient is incarcerated (prisoner)
- Participation in a clinical trial of an investigational drug or device
Where it is running
- 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
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.