Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2026-03-01 @ 8:56 PM
Study NCT ID:
NCT02158403
Status:
COMPLETED
Last Update Posted:
2022-03-25
First Post:
2014-05-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PREVENtion of HeartMate II Pump Thrombosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013927', 'term': 'Thrombosis'}], 'ancestors': [{'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-24', 'studyFirstSubmitDate': '2014-05-30', 'studyFirstSubmitQcDate': '2014-06-04', 'lastUpdatePostDateStruct': {'date': '2022-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-06-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of confirmed pump thrombosis within three months of HeartMate II (HM II) implantation', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Incidence of confirmed pump thrombosis within six months of HM II implantation', 'timeFrame': '6 months'}, {'measure': 'Incidence of suspected pump thrombosis (including unexplained hemolysis) within three and six months of HM II implantation', 'timeFrame': '3 and 6 months'}, {'measure': 'Incidence of pump exchange, urgent transplantation or death due to pump thrombosis within three and six months of HM II implantation', 'timeFrame': '3 and 6 months'}, {'measure': 'Survival on LVAD support at six months post HM II implantation', 'timeFrame': '6 months'}, {'measure': 'Multivariate analysis of risk factors for pump thrombosis including demographics, anti-coagulation regimen, selected laboratory data (INR, LDH, plasma free Hgb), pump position measures, pump parameters and blood pressure', 'timeFrame': 'Baseline and 1 week, 1 month, 3 months and 6 months after surgery'}, {'measure': 'Subgroup analysis of subjects identified as having a hypercoagulable disorder prior to HM II implantation', 'timeFrame': 'Baseline and 3 months after implant'}, {'measure': 'Characterization of pump position in the study population (measured via quantitative assessment of X-ray images including inflow cannula angle, outflow cannula angle and pump pocket depth)', 'timeFrame': '1 week and 6 months after surgery'}, {'measure': 'Characterization of selected lab values (INR, LDH and plasma free Hgb) within the study population', 'timeFrame': 'Baseline, 1 week (plus or minus 3 days), 1 month (plus or minus 7 days), 3 months and 6 months (plus or minus 30 days) after surgery'}, {'measure': 'Incidence of protocol-defined anticipated adverse events', 'timeFrame': 'Baseline, 1 month , 3 months and 6 months after surgery'}, {'measure': 'Characterization of pump parameters in the study population including power (watts), speed (rpm), flow (L/min), and pulsatility index', 'timeFrame': '1 week, 1 month, 3 months, and 6 months after surgery'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['HeartMate II', 'heart assist device', 'pump thrombosis', 'hypercoagulable disorder', 'thrombus', 'Thoratec Corporation'], 'conditions': ['HeartMate II Pump Thrombosis']}, 'referencesModule': {'references': [{'pmid': '36731068', 'type': 'DERIVED', 'citation': 'Jeske W, Ransom J, Katz JN, Kilic A, Lindenfeld J, Egnaczyk G, Shah P, Brieke A, Uriel N, Crandall D, Farrar DJ, Walenga JM. Enhanced Thrombin Formation in Patients With Ventricular Assist Devices Experiencing Bleeding: Insights From the Multicenter PREVENT Study. ASAIO J. 2023 Mar 1;69(3):278-283. doi: 10.1097/MAT.0000000000001790. Epub 2022 Sep 8.'}, {'pmid': '29952801', 'type': 'DERIVED', 'citation': 'Kilic A, Ransom J, Maltais S, Sun B, Entwistle JW 3rd, Bailey S, John R, Klodell CT, Gregoric I, Sheridan B, Chuang J, Farrar DJ, Sundareswaran K, Adamson R. Pump Position Impacts HeartMate II Left Ventricular Assist Device Thrombosis. ASAIO J. 2019 Mar/Apr;65(3):227-232. doi: 10.1097/MAT.0000000000000840.'}, {'pmid': '29153636', 'type': 'DERIVED', 'citation': 'Thenappan T, Stulak JM, Agarwal R, Maltais S, Shah P, Eckman P, Emani S, Katz JN, Gregoric I, Keebler ME, Uriel N, Adler E, Chuang J, Farrar DJ, Sundareswaran KS, John R. Early intervention for lactate dehydrogenase elevation improves clinical outcomes in patients with the HeartMate II left ventricular assist device: Insights from the PREVENT study. J Heart Lung Transplant. 2018 Jan;37(1):25-32. doi: 10.1016/j.healun.2017.10.017. Epub 2017 Oct 24.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess how often blood clots form in the FDA-approved HeartMate® II (HM II) Left Ventricular Assist Device (LVAD) and to identify risks related to clotting within the pump.', 'detailedDescription': 'PREVENT is a prospective, multi-center, non-randomized study that is designed (1) to assess the incidence of HM II pump thrombosis in the current era when recommended practices for clinical management are adopted, and (2) to identify the risk factors associated with pump thrombosis events. The recommended practices are focused on implantation technique, anticoagulation regimen, pump speed and blood pressure management. All consecutive patients receiving a HM II implant will be considered for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject or legally authorized representative has signed an informed consent form\n* Subject is receiving the HeartMate II as their first Left Ventricular Assist Device (LVAD)\n\nExclusion Criteria:\n\n* Prior mechanical circulatory support (MCS) (except for intra-aortic balloon pump)\n* Participation in any other clinical investigation(s) involving a MCS device, or an investigation(s) that is likely to confound study results or affect study outcome'}, 'identificationModule': {'nctId': 'NCT02158403', 'acronym': 'PREVENT', 'briefTitle': 'PREVENtion of HeartMate II Pump Thrombosis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'PREVENtion of HeartMate II Pump Thrombosis Through Clinical Management', 'orgStudyIdInfo': {'id': 'TC05232014'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Clinical Management Recommendations', 'description': 'Clinical management recommendations for reducing pump thrombosis', 'interventionNames': ['Other: Clinical Management Recommendations for reducing pump thrombosis']}], 'interventions': [{'name': 'Clinical Management Recommendations for reducing pump thrombosis', 'type': 'OTHER', 'description': 'Clinical Management Recommendations for reducing pump thrombosis', 'armGroupLabels': ['Clinical Management Recommendations']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Baptist Medical Center', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Diego', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Sutter Memorial', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '92123', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Sharp Memorial Hospital', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Shands Hospital at University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern Memorial', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Jewish Hospital', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Abbott Northwestern', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55455', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'University of Minnesota Medical Center', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': "Mayo Clinic, St. Mary's", 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19001', 'city': 'Abington', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Abington Memorial Hospital', 'geoPoint': {'lat': 40.12067, 'lon': -75.11795}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pittsburgh Medical Center', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann/UT Texas', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '22042', 'city': 'Falls Church', 'state': 'Virginia', 'country': 'United States', 'facility': 'Inova Fairfax Hospital', 'geoPoint': {'lat': 38.88233, 'lon': -77.17109}}], 'overallOfficials': [{'name': 'Kartik Sundareswaran, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abbott'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Thoratec Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}