Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02326402
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TandemHeart Experiences and MEthods (THEME Registry)
Sponsor:
CardiacAssist, Inc.
Organization:
Study Overview
Official Title:
THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
Status:
TERMINATED
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Sponsor Decision
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
THEME
Brief 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.
Detailed Description:
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: