Ignite Creation Date:
2025-12-25 @ 3:26 AM
Ignite Modification Date:
2025-12-26 @ 2:06 AM
Study NCT ID:
NCT04945005
Status:
COMPLETED
Last Update Posted:
2021-06-30
First Post:
2021-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-21', 'studyFirstSubmitDate': '2021-06-15', 'studyFirstSubmitQcDate': '2021-06-21', 'lastUpdatePostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-06-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)', 'timeFrame': '2 - 7 days post-implant (at hospital discharge)', 'description': 'Lead induced tricuspid regurgitation measured by transthoracic echocardiography'}], 'secondaryOutcomes': [{'measure': 'Dose-are product', 'timeFrame': 'Intraprocedural', 'description': 'Dose-are product applied during lead implantation'}, {'measure': 'Lead revisions', 'timeFrame': '30 days', 'description': 'Incidence of acute lead revisions within 30 days'}, {'measure': 'Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)', 'timeFrame': '3 months', 'description': 'Lead induced tricuspid regurgitation measured by transthoracic echocardiography'}, {'measure': 'Increase of tricuspid regurgitation by at least one grade (on a scale from 0-4)', 'timeFrame': '12 months', 'description': 'Lead induced tricuspid regurgitation measured by transthoracic echocardiography'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Tricuspid Valve Insufficiency', 'Pacemaker Complication', 'Echocardiography, Transesophageal']}, 'referencesModule': {'references': [{'pmid': '34887055', 'type': 'DERIVED', 'citation': 'Gmeiner J, Sadoni S, Orban M, Fichtner S, Estner H, Massberg S, Hagl C, Nabauer M, Hausleiter J, Braun D. Prevention of Pacemaker Lead-Induced Tricuspid Regurgitation by Transesophageal Echocardiography Guided Implantation. JACC Cardiovasc Interv. 2021 Dec 13;14(23):2636-2638. doi: 10.1016/j.jcin.2021.08.042. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Registry for patients undergoing pacemaker/ICD implantation including a transtricuspid lead with and without intraprocedural transesophageal echocardiography to evaluate risk factors for lead induced tricuspid regurgitation.', 'detailedDescription': 'Lead induced tricuspid regurgitation is a common finding after pacemaker/ICD Implantation. Transesophageal echocardiography (TEE) might be used to guide lead implantations in order to prevent tricuspid regurgitation.\n\nIn this registry, patients undergoing pacemaker/ICD implantation including a transtricuspid lead are enrolled. While in most patients lead implantation is guided by fluroscopy, in some patients lead implantation is guided by TEE in addition to fluroscopy.\n\nAims of this registry: Evaluation of\n\n* Incidence of lead induced tricuspid regurgitation\n* Mortality and morbidity of lead induced tricuspid regurgitation\n* Identification of risk factors for lead induced tricuspid regurgitation\n* Influence of the lead position within the tricuspid valve on the incidence of lead induced tricuspid regurgitation\n* Prevention of lead induced tricuspid regurgitation by TEE-guided lead implantation'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All adult patients undergoing pacemaker/ICD implantation including a transtricuspid lead were included in this registry.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* indication for pacemaker/ICD implantation including a transtricuspid lead according to guidelines\n\nExclusion Criteria:\n\n* pre-existing RV lead\n* pre-existing TR \\>2'}, 'identificationModule': {'nctId': 'NCT04945005', 'acronym': 'PLACE', 'briefTitle': 'Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': 'Prevention of Pacemaker Lead Induced Tricuspid regurgitAtion by Transesophageal eCho guidEd Implantation Registry', 'orgStudyIdInfo': {'id': '101214'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lead implantation with transesophageal echocardiography', 'description': 'All patients undergoing pacemaker/CRT implantation with concomitant transesophageal echocardiography in addition to fluoroscopic guidance', 'interventionNames': ['Procedure: Transesophageal guidance of lead implantation']}, {'label': 'Lead implantation without transesophageal echocardiography (retrospective)', 'description': 'All patients undergoing standard pacemaker/CRT implantation guided by fluoroscopy only (retrospective historical control group)'}], 'interventions': [{'name': 'Transesophageal guidance of lead implantation', 'type': 'PROCEDURE', 'description': 'In patients undergoing lead implantation including transesophageal echocardiography for clinical reasons (e.g. intraprocedural cardioversion), echocardiography was also used for guidance of lead implantation to reduce lead-leaflet interactions', 'armGroupLabels': ['Lead implantation with transesophageal echocardiography']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'LMU Klinikum', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Daniel Braun, PD Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMU Klinikum'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Physician', 'investigatorFullName': 'Daniel Braun, MD', 'investigatorAffiliation': 'LMU Klinikum'}}}}