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TandemHeart Experiences and MEthods (THEME Registry) (THEME)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02326402
Recruitment Status : Recruiting
First Posted : December 29, 2014
Last Update Posted : May 22, 2020
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 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 System

Detailed Description:

The TandemHeart percutaneous extracorporeal ventricular assist system is used to support circulation. The percutaneous cannulas facilitate access to the venous and arterial circulatory vessels. When connected to the TandemHeart 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 TandemHeart 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 TandemHeart support will be collected. The THEME Registry will collect descriptive data regarding patient selection criteria and the clinical management of the TandemHeart patient including strategies used to wean and remove the TandemHeart. Specifically the objectives of the THEME registry are:

  • Summarize the characteristics of the patients who receive TandemHeart for temporary percutaneous mechanical support with or without an oxygenator, including demographics, pre-implant medical history, details of present illness, TandemHeart exit strategy.
  • Evaluate the timing of initiation of TandemHeart mechanical 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 TandemHeart 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 TandemHeart insertion.
  • Collect serious adverse events from the time of TandemHeart insertion through removal of the TandemHeart System (or TandemHeart Blood Pump).
  • Provide data regarding TandemHeart case mix, patient characteristics, and outcomes.

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Study Type : Observational
Estimated Enrollment : 200 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 2020
Estimated Study Completion Date : December 2020

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

Primary Outcome Measures :
  1. Survival to TandemHeart 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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
Consented patients in whom the TandemHeart 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).

Inclusion Criteria:

  1. Patient has had the TandemHeart 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 identifier (NCT number): NCT02326402

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

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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
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   
Contact: Jennifer Hajj, BSN, RN    310-423-2634   
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   
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   
Principal Investigator: Stanley Chetcuti, MD         
Henry Ford Hospital Recruiting
Detroit, Michigan, United States, 48202
Contact: Margaret Fox, RN, BSN    313-916-1879   
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: Diéynaba Diagne, MPH    215-662-4320   
Principal Investigator: Christian Bermudez, MD         
Temple University Hospital Recruiting
Philadelphia, Pennsylvania, United States, 19140
Contact: Jennie Wong, RN, CCRP    215-707-5340   
Principal Investigator: Vladimir Lakhter, DO         
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Mike Anselmi, CCP   
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   
Principal Investigator: Andrew T Coletti, MD         
United States, Wisconsin
Medical College of Wisconsin-Froedtert Hospital Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barbara Alivo   
Principal Investigator: David Joyce, MD         
Sponsors and Collaborators
CardiacAssist, Inc.
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: CardiacAssist, Inc. Identifier: NCT02326402    
Other Study ID Numbers: THEME
First Posted: December 29, 2014    Key Record Dates
Last Update Posted: May 22, 2020
Last Verified: May 2020
Keywords provided by CardiacAssist, Inc.:
Circulatory support
Extracorporeal circulatory support
Extracorporeal bypass
Additional relevant MeSH terms:
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Lung Diseases
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases