Ignite Creation Date:
2025-12-24 @ 10:23 PM
Ignite Modification Date:
2025-12-25 @ 7:55 PM
Study NCT ID:
NCT00748735
Status:
COMPLETED
Last Update Posted:
2008-09-09
First Post:
2008-09-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Left Ventricular Lead Position in Cardiac Resynchronization Therapy
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': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 55}}, 'statusModule': {'overallStatus': 'COMPLETED', 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'lastUpdateSubmitDate': '2008-09-08', 'studyFirstSubmitDate': '2008-09-07', 'studyFirstSubmitQcDate': '2008-09-08', 'lastUpdatePostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Improvement in LV function and LV remodelling', 'timeFrame': '6 to 12 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiac resynchronization therapy', 'echocardiography', 'heart failure', 'left ventricular function', 'pacing', 'myocardial deformation imaging', 'Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy'], 'conditions': ['Heart Failure']}, 'referencesModule': {'references': [{'pmid': '17309913', 'type': 'BACKGROUND', 'citation': 'Becker M, Franke A, Breithardt OA, Ocklenburg C, Kaminski T, Kramann R, Knackstedt C, Stellbrink C, Hanrath P, Schauerte P, Hoffmann R. Impact of left ventricular lead position on the efficacy of cardiac resynchronisation therapy: a two-dimensional strain echocardiography study. Heart. 2007 Oct;93(10):1197-203. doi: 10.1136/hrt.2006.095612. Epub 2007 Feb 19.'}, {'pmid': '17426079', 'type': 'BACKGROUND', 'citation': 'Becker M, Kramann R, Franke A, Breithardt OA, Heussen N, Knackstedt C, Stellbrink C, Schauerte P, Kelm M, Hoffmann R. Impact of left ventricular lead position in cardiac resynchronization therapy on left ventricular remodelling. A circumferential strain analysis based on 2D echocardiography. Eur Heart J. 2007 May;28(10):1211-20. doi: 10.1093/eurheartj/ehm034. Epub 2007 Apr 10.'}, {'pmid': '20466342', 'type': 'DERIVED', 'citation': 'Becker M, Altiok E, Ocklenburg C, Krings R, Adams D, Lysansky M, Vogel B, Schauerte P, Knackstedt C, Hoffmann R. Analysis of LV lead position in cardiac resynchronization therapy using different imaging modalities. JACC Cardiovasc Imaging. 2010 May;3(5):472-81. doi: 10.1016/j.jcmg.2009.11.016.'}]}, 'descriptionModule': {'briefSummary': 'Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.', 'detailedDescription': 'In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with end-stage heart failure and sinus rhythm, scheduled for new implantation of a biventricular pacemaker were included in the study. Criteria for CRT implantation were New York Heart Association (NYHA) functional class III (N=35) or IV (N=21) despite optimal pharmacologic therapy and evidence of LV systolic dysfunction with ejection fraction \\<35% and a QRS \\>120ms.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* See above\n* Males and females\n* Ages 18 to 80 years\n\nExclusion Criteria:\n\n* Patients who already have had a pacemaker device\n* Patients with poor echocardiographic window\n* Patients who are not able to understand the study and to give informed written consent'}, 'identificationModule': {'nctId': 'NCT00748735', 'briefTitle': 'Left Ventricular Lead Position in Cardiac Resynchronization Therapy', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging', 'orgStudyIdInfo': {'id': 'MB-2008-CRT'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'A1', 'description': 'heart failure patients undergoing CRT implantation', 'interventionNames': ['Procedure: Implantation of a cardiac resynchronization therapy device', 'Procedure: Echocardiography (myocardial deformation imaging)']}], 'interventions': [{'name': 'Implantation of a cardiac resynchronization therapy device', 'type': 'PROCEDURE', 'armGroupLabels': ['A1']}, {'name': 'Echocardiography (myocardial deformation imaging)', 'type': 'PROCEDURE', 'armGroupLabels': ['A1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52057', 'city': 'Aachen', 'country': 'Germany', 'facility': 'Department of Cardiology, RWTH Aachen University Hospital', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Michael Becker, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'RWTH Aachen University Hospital'}, {'name': 'Rainer Hoffmann, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'RWTH Aachen University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}}}}