TandemHeart Experiences and MEthods (THEME Registry)

CardiacAssist, Inc.

Status: Terminated

Conditions: Lung Diseases; Heart Diseases

Treatments: Device: TandemHeart or LifeSPARC System

Study type: Observational

Funder types: Industry

Identifiers

NCT02326402

THEME

Details and patient eligibility

About

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.

Full 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.

Enrollment: 365 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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