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
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Condition or disease | Intervention/treatment |
---|---|
Heart Diseases Lung Diseases | Device: TandemHeart or LifeSPARC System |
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 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 |
- Device: TandemHeart or LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC SystemOther Names:
- TandemHeart
- LifeSPARC System
- 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
- 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

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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 |
Inclusion Criteria:
- Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)
- Age >= 18
- Patient (or legally authorized representative [LAR]) has signed informed consent
Exclusion Criteria:
- Patient is incarcerated (prisoner)
- Participation in a clinical trial of an investigational drug or device

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
Contact: Christine A Hoyer, RN | 412-963-7770 ext 229 | ||
Contact: Kristie A Burgess, PhD | 412-963-7770 ext 223 |
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 |
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 |
Circulatory support Extracorporeal circulatory support Extracorporeal bypass LifeSPARC |
Lung Diseases Heart Diseases Cardiovascular Diseases Respiratory Tract Diseases |