Ignite Creation Date:
2025-12-25 @ 3:37 AM
Ignite Modification Date:
2026-02-25 @ 5:34 PM
Study NCT ID:
NCT02326402
Status:
TERMINATED
Last Update Posted:
2023-09-21
First Post:
2014-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TandemHeart Experiences and MEthods (THEME Registry)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 365}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'Sponsor Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2023-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-09-18', 'studyFirstSubmitDate': '2014-12-15', 'studyFirstSubmitQcDate': '2014-12-22', 'lastUpdatePostDateStruct': {'date': '2023-09-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-12-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'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', 'timeFrame': '180 Days', 'description': 'Survival'}], 'secondaryOutcomes': [{'measure': 'Occurrence of Serious Adverse Events (SAEs) related to the device while on support', 'timeFrame': 'Approximately 72 hours after start of support', 'description': 'Serious Adverse Events'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Circulatory support', 'Extracorporeal circulatory support', 'Extracorporeal bypass', 'LifeSPARC'], 'conditions': ['Heart Diseases', 'Lung Diseases']}, 'referencesModule': {'references': [{'pmid': '29466925', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nIt 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:\n\n* 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.\n* 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.\n* 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.\n* Collect hospital discharge information including Intensive Care Unit (ICU) and Hospital length of stay (LOS).\n* Collect survival and exit strategy status at 30 and 180 days post-initial System insertion.\n* Collect serious adverse events from the time of Pump insertion through removal of the System (or Pump).\n* Provide data regarding patient characteristics and outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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).', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient has had the TandemHeart or LifeSPARC System inserted percutaneously (e.g. in the cath lab or peri-operatively)\n2. Age \\>= 18\n3. Patient (or legally authorized representative \\[LAR\\]) has signed informed consent\n\nExclusion Criteria:\n\n1. Patient is incarcerated (prisoner)\n2. Participation in a clinical trial of an investigational drug or device'}, 'identificationModule': {'nctId': 'NCT02326402', 'acronym': 'THEME', 'briefTitle': 'TandemHeart Experiences and MEthods (THEME Registry)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CardiacAssist, Inc.'}, 'officialTitle': 'THEME Registry: TandemHeart Experiences and MEthods (THEME Registry)', 'orgStudyIdInfo': {'id': 'THEME'}}, 'armsInterventionsModule': {'interventions': [{'name': 'TandemHeart or LifeSPARC System', 'type': 'DEVICE', 'otherNames': ['TandemHeart', 'LifeSPARC System'], 'description': 'Percutaneous insertion of TandemHeart or LifeSPARC System'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Princeton-Baptist Medical Center', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85724', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner - University Medical Center Tucson', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '62769', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': "St. John's Hospital", 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Health System', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'St. Louis University Hospital', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Hospital of the University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19140', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Temple University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '22908', 'city': 'Charlottesville', 'state': 'Virginia', 'country': 'United States', 'facility': 'University of Virginia Health System', 'geoPoint': {'lat': 38.02931, 'lon': -78.47668}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': "Providence Sacred Heart Medical Center & Children's Hospital", 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin-Froedtert Hospital', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CardiacAssist, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}