Ignite Creation Date:
2025-12-24 @ 11:46 PM
Ignite Modification Date:
2025-12-25 @ 9:39 PM
Study NCT ID:
NCT05820451
Status:
COMPLETED
Last Update Posted:
2024-09-04
First Post:
2023-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impella Real-World Surveillance of Patients Using Sodium Bicarbonate
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012770', 'term': 'Shock, Cardiogenic'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}, {'id': 'D012769', 'term': 'Shock'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 312}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-30', 'studyFirstSubmitDate': '2023-03-24', 'studyFirstSubmitQcDate': '2023-04-07', 'lastUpdatePostDateStruct': {'date': '2024-09-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Endpoint Left Sided Impella', 'timeFrame': 'From hospital admission until hospital discharge, average 5 days', 'description': 'Rate of heiarchical composite of stroke, transient ischemic attack (TIA), left ventricular (LV) thrombus'}, {'measure': 'Primary Endpoint Right Sided Impella', 'timeFrame': 'From hospital admission until hospital discharge, average 5 days', 'description': 'Rate of heiarchical composite of pulmonary thromboemboli and deep vein thrombosis (DVT)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Cardiogenic Shock', 'High Risk PCI']}, 'descriptionModule': {'briefSummary': 'The population enrolled in this study are all subjects who received an Impella in which a bicarbonate-based purge solution was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All subjects who received an Impella in which a bicarbonate-based purge solution was used', 'healthyVolunteers': False, 'eligibilityCriteria': 'Left Sided Impella\n\nInclusion Criteria:\n\n* Left-sided Impella with bicarbonate in the purge\n\nExclusion Criteria:\n\n* Known LV thrombus\n\nRight Sided Impella\n\nInclusion Criteria:\n\n* Right-sided Impella with bicarbonate in the purge\n\nExclusion Criteria:\n\n* Known pulmonary thromboemboli\n* Known DVT'}, 'identificationModule': {'nctId': 'NCT05820451', 'briefTitle': 'Impella Real-World Surveillance of Patients Using Sodium Bicarbonate', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abiomed Inc.'}, 'officialTitle': 'Impella Real-World Surveillance of Patients Using Sodium Bicarbonate', 'orgStudyIdInfo': {'id': 'ABMD-CIP-21-02-SS01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Left sided device', 'description': 'All patients implanted with a left sided support Impella device - this includes but is not limited to Impella 2.5, Impella CP, Impella 5.0, Impella 5.5.', 'interventionNames': ['Device: Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution']}, {'label': 'Right sided device', 'description': 'All patients implanted with a right sided support Impella device -this includes the Impella RP', 'interventionNames': ['Device: Impella RP with Sodium Bicarbonate used as purge solution']}], 'interventions': [{'name': 'Impella CP, 2.5, 5.0 and 5.5 with Sodium Bicarbonate used as purge solution', 'type': 'DEVICE', 'description': 'US commercially approved Abiomed left sided hemodynamic support devices (Impella) will be included.', 'armGroupLabels': ['Left sided device']}, {'name': 'Impella RP with Sodium Bicarbonate used as purge solution', 'type': 'DEVICE', 'description': 'US commercially approved Abiomed right sided hemodynamic support devices (Impella) will be included.', 'armGroupLabels': ['Right sided device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pima Heart and Vascular (Tuscon Medical Center)', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72211', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Heart Hospital', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '90033', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Keck USC Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '32804', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Advent Helath Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '33606', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'Tampa General Hospital', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '48236', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Ascension St. John Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '59802', 'city': 'Missoula', 'state': 'Montana', 'country': 'United States', 'facility': 'Providence St. Patrick', 'geoPoint': {'lat': 46.87215, 'lon': -113.994}}, {'zip': '68105', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '08901', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Robert Wood Johnson University Hospital', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '45219', 'city': 'Cincinnatti', 'state': 'Ohio', 'country': 'United States', 'facility': 'Christ Hospital'}, {'zip': '97205', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Montefiore Medical Center - Moses', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Emanuel', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15213', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'UPMC Presbyterian', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75226', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor Scott and White (Baylor Heart and Vascular)', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '75093', 'city': 'Plano', 'state': 'Texas', 'country': 'United States', 'facility': 'The Heart Hospital Baylor Plano', 'geoPoint': {'lat': 33.01984, 'lon': -96.69889}}, {'zip': '99204', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Providence Sacred Heart', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}, {'zip': '98405', 'city': 'Tacoma', 'state': 'Washington', 'country': 'United States', 'facility': 'MultiCare Tacoma General', 'geoPoint': {'lat': 47.25288, 'lon': -122.44429}}], 'overallOfficials': [{'name': 'Amin Medjamia, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Abiomed Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abiomed Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}