Ignite Creation Date:
2025-12-24 @ 12:03 PM
Ignite Modification Date:
2025-12-27 @ 10:39 PM
Study NCT ID:
NCT00512161
Status:
COMPLETED
Last Update Posted:
2017-01-19
First Post:
2007-08-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Placement of Permanent Pacemaker Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-17', 'studyFirstSubmitDate': '2007-08-03', 'studyFirstSubmitQcDate': '2007-08-06', 'lastUpdatePostDateStruct': {'date': '2017-01-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Any patient undergoing elective cardiac surgery'], 'conditions': ['Cardiac Surgical Procedures']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation.\n\n1. Type of cardiac surgery\n2. Gender of patient\n3. Patient's age\n4. Preoperative heart rhythm and rate\n5. Duration on cardiopulmonary bypass\n6. Immediate post cardiopulmonary bypass heart rhythm and rate.\n7. All heart rhythms and rates identified in the postoperative period prior to permanent pacemaker implantation.\n8. Underlying heart rhythm and rates when permanent pacemaker is placed.\n9. Ejection fraction before surgery\n10. Ejection fraction immediately post-cardiopulmonary bypass", 'detailedDescription': 'The purpose of this study is to determine the predictors for placement of permanent pacemakers soon after cardiac surgery. We will measure the following to see what influence, if any, they have on predicting the need for permanent pacemaker implantation. Through investigation into the co-morbidities, diagnoses, or histories associated with an endpoint permanent pacemaker placement, it is possible that we will garner a better idea of who will require PPP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Cardiopulmonary Bypass Patients without a pacemaker already in place', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients between the ages of 18-99 years.\n* All patients undergoing cardiac surgery requiring cardiopulmonary bypass.\n\nExclusion Criteria:\n\n* Patients who have permanent pacemakers in place.'}, 'identificationModule': {'nctId': 'NCT00512161', 'briefTitle': 'Placement of Permanent Pacemaker Study', 'organization': {'class': 'OTHER', 'fullName': 'Weill Medical College of Cornell University'}, 'officialTitle': 'A Retrospective Study to Determine the Frequency of Indications That Lead to the Placement of Permanent Pacemakers After Cardiac Surgery', 'orgStudyIdInfo': {'id': '0701008942'}}, 'contactsLocationsModule': {'locations': [{'zip': '10026', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Weill Medical College of Cornell University', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Gregory E. Kerr, M.D., M.B.A.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Weill Medical College of Cornell University'}, {'name': 'John J. Savarese, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Weill Medical College of Cornell University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}