Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT01294267
Status:
COMPLETED
Last Update Posted:
2018-02-14
First Post:
2011-01-25
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017180', 'term': 'Tachycardia, Ventricular'}], 'ancestors': [{'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vivek.reddy@mountsinai.org', 'phone': '212-241-7114', 'title': 'Vivek Y. Reddy, MD', 'organization': 'Icahn School of Medicine at Mount Sinai, Helmsley Electrophysiology Center'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The lack of a control group precludes drawing definitive conclusions between the lack of either statistically or clinically significant changes in perioperative markers of end-organ perfusion/function and the use of a pLVAD.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.', 'otherNumAtRisk': 20, 'deathsNumAtRisk': 20, 'otherNumAffected': 3, 'seriousNumAtRisk': 20, 'deathsNumAffected': 2, 'seriousNumAffected': 5}], 'otherEvents': [{'term': 'Acute Kidney Injury', 'notes': 'an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline), and all resolved within 72 hours', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 20, 'numAffected': 3}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Death', 'notes': 'death from any cause', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Hospitalization', 'notes': 'hospitalization for any cause, within 30 days', 'stats': [{'groupId': 'EG000', 'numAtRisk': 20, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.\n\nCirculatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects'}], 'classes': [{'title': 'Complete procedural sucess', 'categories': [{'measurements': [{'value': '8', 'groupId': 'OG000'}]}]}, {'title': 'Partial procedural sucess', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Inpatient Admission', 'description': 'Satisfactory hemodynamic status during the ablation procedure \\[during VT Mapping and Ablation Procedure\\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Clinical Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.\n\nCirculatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects'}], 'classes': [{'title': 'Death from any cause', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Hospitalization for any cause', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Sustained VT/ICD therapy', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '1 Month post ablation Follow up', 'description': 'Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month \\[30 days\\] follow up telephone interview to assess symptoms, side effects and medication use.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Safety Outcomes', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.\n\nCirculatory Support System: Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects'}], 'classes': [{'title': 'Acute kidney injury stage 1', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Postop cognitive dysfunction', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '30 day', 'description': 'Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline.\n\nA decline in neurocognitive function, as defined by a decrease in MMSE ≥2 points from the baseline score, after the procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Twenty consecutive patients with scar VT underwent ablation between Sept 2010 and July 2011.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.5', 'spread': '11.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Chronic Kidney Disease', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diabetes Mellitus', 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-17', 'studyFirstSubmitDate': '2011-01-25', 'resultsFirstSubmitDate': '2017-04-18', 'studyFirstSubmitQcDate': '2011-02-09', 'lastUpdatePostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-01-17', 'studyFirstPostDateStruct': {'date': '2011-02-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2018-02-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Safety Outcomes', 'timeFrame': '30 day', 'description': 'Acute Kidney Injury Network stage 1 kidney injury (ie, an absolute increase in serum creatinine of ≥0.3 mg/dL or percentage increase of 150%-200% from baseline.\n\nA decline in neurocognitive function, as defined by a decrease in MMSE ≥2 points from the baseline score, after the procedure.'}], 'primaryOutcomes': [{'measure': 'Number of Participants With Procedural Success', 'timeFrame': 'Inpatient Admission', 'description': 'Satisfactory hemodynamic status during the ablation procedure \\[during VT Mapping and Ablation Procedure\\], utilizing the Hemodynamic Support of Impella 2.5 Circulatory Support System'}], 'secondaryOutcomes': [{'measure': 'Clinical Outcomes', 'timeFrame': '1 Month post ablation Follow up', 'description': 'Morbidity and Mortality, as determined by clinical metrics and validated by tests during and immediately post VT Mapping and ablation procedure with cardiac monitoring in hospital and one Month \\[30 days\\] follow up telephone interview to assess symptoms, side effects and medication use.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Ventricular Tachycardia', 'Radio Frequency Ablation', 'Percutaneous Left Ventricular Assist Device', 'Hemodynamic Management', 'Interventional Cardiac Procedure', 'Mechanical Cardiac Assistance', 'Intra-Aortic Balloon Pump', 'Coronary Intervention', 'Impella 2.5', 'Circulation Support system'], 'conditions': ['Ventricular Tachycardia']}, 'referencesModule': {'references': [{'pmid': '23255277', 'type': 'DERIVED', 'citation': "Miller MA, Dukkipati SR, Chinitz JS, Koruth JS, Mittnacht AJ, Napolitano C, d'Avila A, Reddy VY. Percutaneous hemodynamic support with Impella 2.5 during scar-related ventricular tachycardia ablation (PERMIT 1). Circ Arrhythm Electrophysiol. 2013 Feb;6(1):151-9. doi: 10.1161/CIRCEP.112.975888. Epub 2012 Dec 19."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this research study is to evaluate the safety and feasibility of the Impella 2.5 Circulatory Support System for use during mapping and ablation of ventricular tachycardia in the setting of Ventricular dysfunction.', 'detailedDescription': "The Impella 2.5 is a percutaneous heart pump that will be used to provide partial circulatory support -. The Impella 2.5 is approved by the US Food and Drug Administration and is being tested to see if it helps keep the patient's blood pressure stable during the cardiac ablation procedure. The Impella 2.5 Circulatory Support System works by placing a small pump into the left pumping chamber of the heart which will then help the heart circulate blood throughout the body. The Impella 2.5 Circulatory Support system will be removed once the heart no longer needs help with the pumping action which can be at any time from just after the completion of the heart procedure up to several days post procedure as determined by physician."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* male or female\n* age 18 to 90 years\n* catheter ablation of ventricular tachycardia\n* Left Ventricular ejection fraction less than or equal to 40% or hypertrophic cardiomyopathy\n\nExclusion Criteria:\n\n* Any reversible cause of VT \\[electrolyte derangements, medication related itc\\]\n* Evidence of active, ongoing cardiac ischemia as the cause of VT\n* Patients who have experienced any cerebral ischemic event including any TIA in the preceding one month\n* Mural thrombus in left Ventricle\n* Presence of mechanical aortic valve\n* Severe Aortic Stenosis \\[orifice area of 2.0 cm2 or less\\] or moderate to severe aortic insufficiency\n* Severe abnormalities of the aorta that would preclude Impella insertion, including aneurysms and extreme tortuosity or calcifications\n* Liver dysfunction or markedly abnormal coagulation parameters \\[as defined by platelet count less than or equal to 50,000/ul\\]\n* Any condition resulting in contraindication to anticoagulation \\[eg GI bleeding\\]\n* Women who are known to be pregnant or have had a positive B-HCG test 7 days prior to procedure\n* Patients whose life expectancy is less than one year\n* Mental Impairment precluding patient or family from providing informed consent or completing the appropriate follow up'}, 'identificationModule': {'nctId': 'NCT01294267', 'acronym': 'PERMIT1', 'briefTitle': 'Percutaneous Hemodynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'PERcutaneous heModynamic Support With Impella 2.5 During Scar-related Ventricular Tachycardia Ablation', 'orgStudyIdInfo': {'id': 'GCO 10-1423'}, 'secondaryIdInfos': [{'id': 'BRANY IRB-10-02-154-05', 'type': 'OTHER', 'domain': 'BRANY - Biomedical Research Alliance of New York, an institutional review board fully accredited by AAHRPP'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Circulatory Support System', 'description': 'Percutaneous use of left ventricular assist device, Impella 2.5 Circulatory Support System to facilitate mapping and ablation of ongoing VT by maintaining near-normal hemodynamics, reducing myocardial workload and preservice organ perfusion.', 'interventionNames': ['Device: Circulatory Support System']}], 'interventions': [{'name': 'Circulatory Support System', 'type': 'DEVICE', 'otherNames': ['Impella 2.5 Circulatory Support system insertion'], 'description': 'Femoral angiography will be performed, and if the anatomy is suitable, the femoral artery preclosure technique will be employed. The Impella 2.5 will be inserted through th femoral artery into the left ventricle. Anti-coagulation will be titrated to achieve a therapeutic ACT level. Organ perfusion and Hemodynamic data will be collected during simulated VTs and throughout the course of the case. The performance level of the device may be adjusted during the case to quantify hemodynamic effects', 'armGroupLabels': ['Circulatory Support System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Vivek Reddy, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vivek Reddy', 'class': 'OTHER'}, 'collaborators': [{'name': 'Abiomed Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'DIRECTOR CARDIAC ARRHYTHMIA SERVICE, PROFESSOR OF MEDICINE', 'investigatorFullName': 'Vivek Reddy', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}