Ignite Creation Date:
2025-12-25 @ 4:58 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT01168518
Status:
COMPLETED
Last Update Posted:
2014-09-29
First Post:
2010-07-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
An Observational Study on the Sorin Group New Brady Leads XFine and Beflex
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2254}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-09', 'completionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-09-26', 'studyFirstSubmitDate': '2010-07-22', 'studyFirstSubmitQcDate': '2010-07-22', 'lastUpdatePostDateStruct': {'date': '2014-09-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-07-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Lead dislodgment rate in acute phase', 'timeFrame': 'Lead dislodgment', 'description': 'Ventricular active fixation leads = 1.57%; Ventricular passive fixation leads = 3.23%, Atrial active fixation leads = 1.04%'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Evaluate the Sorin Group new passive- and active- fixation pacing leads'], 'conditions': ['Pacing Leads Implantation']}, 'descriptionModule': {'briefSummary': 'This observational study is a non-interventional multi-centre, prospective study.\n\nThe aim of the study is to evaluate the Sorin Group new passive- and active- fixation pacing leads. We plan to assess the acute and short term lead dislodgment rate (within the first three months following implantation) correlated with the type of lead (active- or passive- fixation). Further, we are collecting data related to leads handling and leads electrical performances', 'detailedDescription': 'The primary objective of this observational study is to assess the acute rate of dislodgment of the new Sorin group range of active- and passive- fixation leads up to 3 months following implant.\n\nAssessment of electrical performances (pacing threshold, sensing amplitude, impedance) of the leads at implant and during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Any patient implanted with an endocavitary pacing lead (atrial and/or ventricular) connected to a single, double or triple chamber pacemaker or defibrillator.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The implanted lead must allow the measurement of pacing threshold at 0.5ms, R-wave or P-wave amplitude and impedance of the lead.\n* Included patients may receive more than one lead under evaluation.\n\nExclusion Criteria:\n\n* Any contraindication to endocavitary lead implantation;\n* Inability to understand the purpose of the study or refusal to co-operate.\n* Geographically unstable or unavailability for scheduled M1-M3 follow-up at the implanting centre as defined in the investigational plan.\n* Patient of minor age (\\<18)\n* Pregnancy.'}, 'identificationModule': {'nctId': 'NCT01168518', 'acronym': 'XFine & Beflex', 'briefTitle': 'An Observational Study on the Sorin Group New Brady Leads XFine and Beflex', 'organization': {'class': 'INDUSTRY', 'fullName': 'LivaNova'}, 'officialTitle': 'Performance of the New Generation of Sorin Group Brady Leads In a Normal Hospital Practice', 'orgStudyIdInfo': {'id': 'RLEA01-FINE'}, 'secondaryIdInfos': [{'id': 'RLEA01'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Perpignan', 'state': 'Perpignan', 'country': 'France', 'facility': 'Clinique St Pierre', 'geoPoint': {'lat': 42.69764, 'lon': 2.89541}}], 'overallOfficials': [{'name': 'Henri Benkemoun, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Unité de Cardiologie et Rythmologie Interventionelle, Perpignan France'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LivaNova', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}