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TandemHeart Experiences and MEthods (THEME Registry) (THEME)

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ClinicalTrials.gov Identifier: NCT02326402
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : March 8, 2022
Sponsor:
Information provided by (Responsible Party):
CardiacAssist, Inc.

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.

Condition or disease Intervention/treatment
Heart Diseases Lung Diseases Device: TandemHeart or LifeSPARC System

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.

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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
Study Start Date : December 2014
Estimated Primary Completion Date : June 2023
Estimated Study Completion Date : December 2023

Intervention Details:
  • Device: TandemHeart or LifeSPARC System
    Percutaneous insertion of TandemHeart or LifeSPARC System
    Other Names:
    • TandemHeart
    • LifeSPARC System


Primary Outcome Measures :
  1. 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 [ Time Frame: 180 Days ]
    Survival


Secondary Outcome Measures :
  1. Occurrence of Serious Adverse Events (SAEs) related to the device while on support [ Time Frame: Approximately 72 hours after start of support ]
    Serious Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02326402


Contacts
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Contact: Christine A Hoyer, RN 412-963-7770 ext 229
Contact: Kristie A Burgess, PhD 412-963-7770 ext 223

Locations
Show Show 18 study locations
Sponsors and Collaborators
CardiacAssist, Inc.
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: CardiacAssist, Inc.
ClinicalTrials.gov Identifier: NCT02326402    
Other Study ID Numbers: THEME
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: March 8, 2022
Last Verified: September 2021
Keywords provided by CardiacAssist, Inc.:
Circulatory support
Extracorporeal circulatory support
Extracorporeal bypass
LifeSPARC
Additional relevant MeSH terms:
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Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases