Heart Diseases, Lung Diseases
Conditions
Keywords
Circulatory support, Extracorporeal circulatory support, Extracorporeal bypass, LifeSPARC
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.
Interventions
DEVICETandemHeart or LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC System
Sponsors
CardiacAssist, Inc.
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively) 2. Age \>= 18 3. Patient (or legally authorized representative \[LAR\]) has signed informed consent
Exclusion criteria
1. Patient is incarcerated (prisoner) 2. Participation in a clinical trial of an investigational drug or device
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 180 Days | Survival |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Occurrence of Serious Adverse Events (SAEs) related to the device while on support | Approximately 72 hours after start of support | Serious Adverse Events |
Countries
United States
Outcome results
None listed