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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02326402
Other study ID # THEME
Secondary ID
Status Terminated
Phase
First received
Last updated
Start date December 2014
Est. completion date January 2023

Study information

Verified date September 2023
Source CardiacAssist, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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 LifeSPARCâ„¢ System for mechanical support and enhance knowledge of best practice regarding clinical management, weaning and removal/exit strategies.


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 Registryâ„¢ 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.


Recruitment information / eligibility

Status Terminated
Enrollment 365
Est. completion date January 2023
Est. primary completion date December 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
TandemHeart or LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC System

Locations

Country Name City State
United States University of Michigan Health System Ann Arbor Michigan
United States Princeton-Baptist Medical Center Birmingham Alabama
United States Brigham and Women's Hospital Boston Massachusetts
United States Massachusetts General Hospital Boston Massachusetts
United States University of Virginia Health System Charlottesville Virginia
United States Henry Ford Hospital Detroit Michigan
United States University of California, San Diego La Jolla California
United States Cedars-Sinai Medical Center Los Angeles California
United States Medical College of Wisconsin-Froedtert Hospital Milwaukee Wisconsin
United States Hospital of the University of Pennsylvania Philadelphia Pennsylvania
United States Temple University Hospital Philadelphia Pennsylvania
United States University of Pittsburgh Medical Center Pittsburgh Pennsylvania
United States St. Louis University Hospital Saint Louis Missouri
United States Providence Sacred Heart Medical Center & Children's Hospital Spokane Washington
United States St. John's Hospital Springfield Illinois
United States Banner - University Medical Center Tucson Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
CardiacAssist, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Survival 180 Days
Secondary Occurrence of Serious Adverse Events (SAEs) related to the device while on support Serious Adverse Events Approximately 72 hours after start of support
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