TandemHeart Experiences and MEthods (THEME Registry) (THEME)
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|ClinicalTrials.gov Identifier: NCT02326402|
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : March 8, 2022
|Condition or disease||Intervention/treatment|
|Heart Diseases Lung Diseases||Device: TandemHeart or LifeSPARC System|
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.
|Study Type :||Observational|
|Estimated Enrollment :||450 participants|
|Official Title:||THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||June 2023|
|Estimated Study Completion Date :||December 2023|
- Device: TandemHeart or LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC SystemOther Names:
- LifeSPARC System
- Survival to Pump removal with myocardial and/or pulmonary recovery, durable ventricular assist device (VAD) implant or transition to another mechanical support device, or cardiac and/or lung transplant [ Time Frame: 180 Days ]Survival
- Occurrence of Serious Adverse Events (SAEs) related to the device while on support [ Time Frame: Approximately 72 hours after start of support ]Serious Adverse Events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326402
|Contact: Christine A Hoyer, RN||412-963-7770 ext 229|
|Contact: Kristie A Burgess, PhD||412-963-7770 ext 223|