TandemHeart Experiences and MEthods (THEME Registry)

Heart Diseases Clinical Trial

— THEME  

Official title:

THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02326402
• Other study ID #: THEME
• Status: Terminated
• 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
• 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 LifeSPARC™ 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 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.

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

Related Conditions & MeSH terms

• Heart Diseases
• Lung Diseases

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