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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 : September 30, 2020
Sponsor:
Information provided by (Responsible Party):
CardiacAssist, Inc.

Study Description
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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.
Study Design
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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
Groups and Cohorts
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Intervention Details:
  • Device: TandemHeart or LifeSPARC System
    Percutaneous insertion of TandemHeart or LifeSPARC System
    Other Names:
    • TandemHeart
    • LifeSPARC System

Outcome Measures
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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


Eligibility Criteria
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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
Contacts and Locations
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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
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United States, Alabama
Princeton-Baptist Medical Center Recruiting
Birmingham, Alabama, United States, 35233
Contact: Ronald Roan, MD    205-488-4801      
Principal Investigator: Ronald Roan, MD         
University of Alabama at Birmingham Withdrawn
Birmingham, Alabama, United States, 35294
United States, Arizona
Banner - University Medical Center Tucson Active, not recruiting
Tucson, Arizona, United States, 85724
United States, California
University of California, San Diego Recruiting
La Jolla, California, United States, 92037
Contact: Carol Battikha Elias       celiasbattikha@health.ucsd.edu   
Principal Investigator: Eric Adler, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: M. Vincent Aguillon, RN BSN CCRN    310-423-1758    Mario.Aguillon@cshs.org   
Principal Investigator: Danny Ramzy, MD, PhD         
United States, Illinois
St. John's Hospital Recruiting
Springfield, Illinois, United States, 62769
Contact: Kelse Mather    217-492-9100 ext 29122    kmather@prairieresearch.com   
Principal Investigator: Nilesh Goswami, MD         
United States, Michigan
University of Michigan Health System Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Allison Schley    734-232-4277    schleya@med.umich.edu   
Principal Investigator: Stanley Chetcuti, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN, BSN    313-916-1879    mfox2@hfhs.org   
Principal Investigator: Khaldoon Alaswad, MD,FACC         
United States, Minnesota
Mayo Clinic Hospital, Saint Marys Campus Withdrawn
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Hospital of the University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Christina Rosario         
Contact       christina.rosario@pennmedicine.upenn.edu   
Principal Investigator: Christian Bermudez, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Sharon Collins       tug41201@temple.edu   
Principal Investigator: Vladimir Lakhter, DO         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Tina Vita, RN, CCRC         
Contact       vitatm@upmc.edu   
Principal Investigator: Pablo Sanchez, MD         
United States, Texas
Baylor College of Medicine Withdrawn
Houston, Texas, United States, 77030
United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Allison Raymond, MPH, BSN, RN    434-982-1058    AEH4M@HSCMAIL.MCC.VIRGINIA.EDU   
Principal Investigator: Michael Ragosta, MD         
United States, Washington
Providence Sacred Heart Medical Center & Children's Hospital Recruiting
Spokane, Washington, United States, 99204
Contact: Lisa Passey, RN,BSN,CCRA    509-474-2041    Lisa.Passey@providence.org   
Principal Investigator: Andrew T Coletti, MD         
United States, Wisconsin
Medical College of Wisconsin-Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Emily Neumann       eneumann@mcw.edu   
Principal Investigator: David Joyce, MD         
Sponsors and Collaborators
CardiacAssist, Inc.
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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: September 30, 2020
Last Verified: September 2020
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