Clinical trial NCT02326402: TandemHeart Experiences and MEthods (THEME Registry)
Official title: THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Diseases
Lung Diseases
Keywords: Circulatory support
Extracorporeal circulatory support
Extracorporeal bypass
LifeSPARC
Lead sponsor: CardiacAssist, Inc.
Sponsor class: INDUSTRY
First posted: 2014-12-29
Enrollment: 365
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in whom the System has been inserted percutaneously (e.g. in the cath lab or peri-operatively) for any diagnosis/condition at an institution participating in the THEME Registry (or transferred to an institution participating in the THEME Registry following insertion).

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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: 180 Days
Secondary outcomes:
measure: Occurrence of Serious Adverse Events (SAEs) related to the device while on support
timeFrame: Approximately 72 hours after start of support
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Princeton-Baptist Medical Center
state: Alabama
city: Tucson
country: United States
facility: Banner - University Medical Center Tucson
state: Arizona
city: La Jolla
country: United States
facility: University of California, San Diego
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Springfield
country: United States
facility: St. John's Hospital
state: Illinois
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan Health System
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Saint Louis
country: United States
facility: St. Louis University Hospital
state: Missouri
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Philadelphia
country: United States
facility: Temple University Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Spokane
country: United States
facility: Providence Sacred Heart Medical Center & Children's Hospital
state: Washington
city: Milwaukee
country: United States
facility: Medical College of Wisconsin-Froedtert Hospital
state: Wisconsin
Study officials:
References:
citation: Rao P, Mosier J, Malo J, Dotson V, Mogan C, Smith R, Keller R, Slepian M, Khalpey Z. Peripheral VA-ECMO with direct biventricular decompression for refractory cardiogenic shock. Perfusion. 2018 Sep;33(6):493-495. doi: 10.1177/0267659118761558. Epub 2018 Feb 21.