Ignite Creation Date:
2025-12-24 @ 5:15 PM
Ignite Modification Date:
2025-12-27 @ 7:02 PM
Study NCT ID:
NCT00632450
Status:
COMPLETED
Last Update Posted:
2019-02-05
First Post:
2008-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 21}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-01', 'studyFirstSubmitDate': '2008-02-29', 'studyFirstSubmitQcDate': '2008-03-07', 'lastUpdatePostDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2008-03-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '22695763', 'type': 'DERIVED', 'citation': 'Sperzel J, Brandt R, Hou W, Doelger A, Zdarek J, Rosenberg SP, Ryu K, Koh S, Yang M. Intraoperative characterization of interventricular mechanical dyssynchrony using electroanatomic mapping system--a feasibility study. J Interv Card Electrophysiol. 2012 Nov;35(2):189-96. doi: 10.1007/s10840-012-9695-0. Epub 2012 Jun 14.'}]}, 'descriptionModule': {'briefSummary': 'The EnSite Real-Time Cardiac Performance Measurements Study (EnSite RT CPM) is a multicenter, international, acute, non-significant risk study, designed to enroll a maximum of 40 patient. The goal of the study is to collect 3-D systolic/diastolic data with the EnSite NavX Mapping system during a CRT implant.\n\nPatients enrolled in this study will undergo NavX CPM recording of the heart using the EnSite NavX Mapping system during the implantation of a cardiac resynchronization therapy device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients indicated for implantation of a CRT pulse generator', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Be undergoing a new St. Jude Medical CRT-D or CRT-P device implantation\n* Have the ability to provide informed consent for study participation and be willing to comply with the prescribed perioperative evaluations\n\nExclusion Criteria:\n\n* Have a recent myocardial infarction within 40 days prior to enrollment\n* Have undergone cardiac surgery or coronary revascularization procedure within 3 months prior to enrollment or be scheduled for such procedures\n* Be less than 18 years of age\n* Be pregnant women\n* Be currently participating in a clinical study that includes an active treatment arm'}, 'identificationModule': {'nctId': 'NCT00632450', 'acronym': 'EnSite RT CPM', 'briefTitle': 'EnSite Real-Time Cardiac Performance Measurements (RT CPM) Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'EnSite Real-Time Cardiac Performance Measurements Study, a Non-significant Risk Study', 'orgStudyIdInfo': {'id': '40004879'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94086', 'city': 'Sunnyvale', 'state': 'California', 'country': 'United States', 'facility': 'St. Jude Medical', 'geoPoint': {'lat': 37.36883, 'lon': -122.03635}}], 'overallOfficials': [{'name': 'Johannes Sperzel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kerckhoff Klinik GmbH'}, {'name': "Andre d'Avila, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Massachusetts General Hospital'}, {'name': 'Imran Niazi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Arrhythmia Center of Southern Wisconsin, Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}