TandemHeart Experiences and MEthods (THEME Registry)
a study on Heart Disease Lung Diseases
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at La Jolla, California and other locations
- Dates
- study startedestimated completion
- Principal Investigator
- by Eric Adler, MD
Description
Summary
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.
Official Title
THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
Details
The TandemHeart or LifeSPARC percutaneous extracorporeal life support system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart or LifeSPARC centrifugal pump, mechanical support is provided with sufficient cardiac power to perfuse the organs of the body. 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.
Keywords
Heart Diseases Lung Diseases Circulatory support Extracorporeal circulatory support Extracorporeal bypass LifeSPARC TandemHeart or LifeSPARC System
Eligibility
You can join if…
Open to people ages 18 years and up
- 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 CAN'T join if...
- Patient is incarcerated (prisoner)
- Participation in a clinical trial of an investigational drug or device
Locations
- University of California, San Diego
accepting new patients
La Jolla California 92037 United States - Cedars-Sinai Medical Center
accepting new patients
Los Angeles California 90048 United States
Lead Scientist at UCSD
- Eric Adler, MD
Clinical Professor, Medicine.
Details
- Status
- accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- CardiacAssist, Inc.
- ID
- NCT02326402
- Study Type
- Observational
- Last Updated
Please contact me about this study
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Thank you!
The study team should get back to you in a few business days.