Heart DiseasesTHEMENCT02326402
TandemHeart Experiences and MEthods (THEME Registry)
An observational study of Heart Diseases and Lung Diseases, run by CardiacAssist, Inc. at 16 sites in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Diseases, Lung Diseases
- What is being tested?
- TandemHeart or LifeSPARC System
- Type of treatment
- Medical device
- How many people
- 365 participants
- Where
- 16 sitesUnited States
- Study dates
- Dec 2014to Jan 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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
Who cannot join
- Patient is incarcerated (prisoner)
- Participation in a clinical trial of an investigational drug or device
Trial locations and contacts
16 sites in 1 country.
16 sites in 1 country
United States16 sites
University of Michigan Health System
Ann Arbor, Michigan, 48109
Princeton-Baptist Medical Center
Birmingham, Alabama, 35233
Massachusetts General Hospital
Boston, Massachusetts, 02114
Brigham and Women's Hospital
Boston, Massachusetts, 02115
University of Virginia Health System
Charlottesville, Virginia, 22908
Henry Ford Hospital
Detroit, Michigan, 48202
University of California, San Diego
La Jolla, California, 92037
Cedars-Sinai Medical Center
Los Angeles, California, 90048
Medical College of Wisconsin-Froedtert Hospital
Milwaukee, Wisconsin, 53226
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104
Temple University Hospital
Philadelphia, Pennsylvania, 19140
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, 15213
Providence Sacred Heart Medical Center & Children's Hospital
Spokane, Washington, 99204
St. John's Hospital
Springfield, Illinois, 62769
St. Louis University Hospital
St Louis, Missouri, 63110
Banner - University Medical Center Tucson
Tucson, Arizona, 85724
About this study
Official title: THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
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.
Read the 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.
- Conditions
- Heart Diseases, Lung Diseases
- Being tested
- TandemHeart or LifeSPARC System
- Keywords
- Circulatory support, Extracorporeal circulatory support, Extracorporeal bypass, LifeSPARC
- Medical subject headings
- Heart Diseases, Lung Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TandemHeart or LifeSPARC SystemDevice
Also called TandemHeart, LifeSPARC System
Percutaneous insertion of TandemHeart or LifeSPARC System
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 180 Days
Secondary outcomes (1)
Occurrence of Serious Adverse Events (SAEs) related to the device while on support
Serious Adverse Events
Measured: Approximately 72 hours after start of support
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2014 (estimated)
- Study startDec 2014
- Primary completionDec 2022
- Study completionJan 2023
Why it stopped: Sponsor Decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 365 participants (actual)
Sponsor and investigators
- Lead sponsor
- CardiacAssist, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02326402
- Sponsor's protocol ID
- THEME
- Acronym
- THEME
- Status last verified
- Sep 2023
- First submitted
- 15 Dec 2014
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Rao P, Mosier J, Malo J, Dotson V, Mogan C, Smith R, Keller R, Slepian M, Khalpey Z. Peripheral VA-ECMO with direct biventricular decompression for refractory cardiogenic shock. Perfusion. 2018 Sep;33(6):493-495. doi: 10.1177/0267659118761558. Epub 2018 Feb 21.
PubMed 29466925
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)
- ClinicalTrials.gov ID
- NCT02326402
- Acronym / sponsor ID
- THEME / THEME
- Conditions
- Heart Diseases, Lung Diseases
- Keywords
- Circulatory support, Extracorporeal circulatory support, Extracorporeal bypass, LifeSPARC
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Sponsor Decision
- Enrolment
- 365 participants (actual)
- Lead sponsor
- CardiacAssist, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2014 (actual)
- Primary completion
- Dec 2022 (actual)
- Study completion
- Jan 2023 (actual)
- First posted
- 29 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Patient is incarcerated (prisoner)
- Participation in a clinical trial of an investigational drug or device
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TandemHeart or LifeSPARC SystemAlso: TandemHeart, LifeSPARC SystemPercutaneous insertion of TandemHeart or LifeSPARC System | Device | – |
Primary outcome
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
1 secondary outcome
Occurrence of Serious Adverse Events (SAEs) related to the device while on support
Time frame: Approximately 72 hours after start of support
Results and safety
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Derived from this study: PubMed 29466925Rao P, Mosier J, Malo J, Dotson V, Mogan C, Smith R, Keller R, Slepian M, Khalpey Z. Peripheral VA-ECMO with direct biventricular decompression for refractory cardiogenic shock. Perfusion. 2018 Sep;33(6):493-495. doi: 10.1177/0267659118761558. Epub 2018 Feb 21.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
16 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Diseases and Lung Diseases, run by CardiacAssist, Inc. at 16 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02326402, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.