Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2025-12-30 @ 4:07 AM
Study NCT ID:
NCT01829269
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2013-04-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
French Attitude Registry in Case of ICD Lead Replacement
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': 559}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2013-04-09', 'studyFirstSubmitQcDate': '2013-04-09', 'lastUpdatePostDateStruct': {'date': '2019-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-04-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Explanted probes', 'timeFrame': '2 years', 'description': 'Percentage of explanted probes among implanted ones'}], 'secondaryOutcomes': [{'measure': 'Complications of explantation', 'timeFrame': '2 years', 'description': 'Percentage of events during and after explantation of probe'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Defibrillator', 'Explantation of Probe']}, 'referencesModule': {'references': [{'pmid': '19004838', 'type': 'BACKGROUND', 'citation': 'Goette A, Cantu F, van Erven L, Geelen P, Halimi F, Merino JL, Morgan JM; Scientific Initiative Committee of the European Heart Rhythm Association. Performance and survival of transvenous defibrillation leads: need for a European data registry. Europace. 2009 Jan;11(1):31-4. doi: 10.1093/europace/eun301. Epub 2008 Nov 11.'}, {'pmid': '19560098', 'type': 'BACKGROUND', 'citation': 'Wilkoff BL, Love CJ, Byrd CL, Bongiorni MG, Carrillo RG, Crossley GH 3rd, Epstein LM, Friedman RA, Kennergren CE, Mitkowski P, Schaerf RH, Wazni OM; Heart Rhythm Society; American Heart Association. Transvenous lead extraction: Heart Rhythm Society expert consensus on facilities, training, indications, and patient management: this document was endorsed by the American Heart Association (AHA). Heart Rhythm. 2009 Jul;6(7):1085-104. doi: 10.1016/j.hrthm.2009.05.020. Epub 2009 May 22. No abstract available.'}, {'pmid': '19719488', 'type': 'BACKGROUND', 'citation': 'Xu W, Moore HJ, Karasik PE, Franz MR, Singh SN, Fletcher RD. Management strategies when implanted cardioverter defibrillator leads fail: survey findings. Pacing Clin Electrophysiol. 2009 Sep;32(9):1130-41. doi: 10.1111/j.1540-8159.2009.02454.x.'}, {'pmid': '21748302', 'type': 'BACKGROUND', 'citation': 'Rickard J, Wilkoff BL. Extraction of implantable cardiac electronic devices. Curr Cardiol Rep. 2011 Oct;13(5):407-14. doi: 10.1007/s11886-011-0198-x.'}, {'pmid': '10334441', 'type': 'BACKGROUND', 'citation': 'Wilkoff BL, Byrd CL, Love CJ, Hayes DL, Sellers TD, Schaerf R, Parsonnet V, Epstein LM, Sorrentino RA, Reiser C. Pacemaker lead extraction with the laser sheath: results of the pacing lead extraction with the excimer sheath (PLEXES) trial. J Am Coll Cardiol. 1999 May;33(6):1671-6. doi: 10.1016/s0735-1097(99)00074-1.'}, {'pmid': '19121802', 'type': 'BACKGROUND', 'citation': 'Glikson M, Suleiman M, Luria DM, Martin ML, Hodge DO, Shen WK, Bradley DJ, Munger TM, Rea RF, Hayes DL, Hammill SC, Friedman PA. Do abandoned leads pose risk to implantable cardioverter-defibrillator patients? Heart Rhythm. 2009 Jan;6(1):65-8. doi: 10.1016/j.hrthm.2008.10.012. Epub 2008 Oct 11.'}, {'pmid': '11046188', 'type': 'BACKGROUND', 'citation': 'Suga C, Hayes DL, Hyberger LK, Lloyd MA. Is there an adverse outcome from abandoned pacing leads? J Interv Card Electrophysiol. 2000 Oct;4(3):493-9. doi: 10.1023/a:1009860514724.'}], 'seeAlsoLinks': [{'url': 'http://www.sfcardio.fr', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The average survival rate of a defibrillation lead is 91 to 99% at 2 years, 85-95% at 5 years and 60-72% at 8 years. We must also manage alerts for defibrillation probes with a higher complication rate than average. We will therefore be increasingly confronted with faulty sensors or at risk to be replaced.\n\nThere are no standardized approach for replacing defibrillation lead. A record made in the United States showed significant differences according to the teams strategy in case of failure of defibrillation lead in particular with regard to the decision to explant or abandon the probe.\n\nThe risk of extracting a defibrillation lead are well known with a major complication rate of 1.6 to 1.95%.\n\nRegarding the risk of complications related to the abandonment of a probe we have less data. For some there is no risk to abandon a defibrillation lead. But others reported a complication rate of 5.5% related to pacing discontinued.\n\nMain objective: Collect the attitude of different centers and different operators when replacing a failed defibrillation lead or "at risk." Explantation or abandonment of the sensor replaced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Centers are hospitals recruiters French public or private, authorized to ask defibrillators and who agreed to participate in the study. A cardiologist referral will be designated for each hospital.\n\nPatients with a defibrillator will be recruited during their hospitalization for change probe. Patients will receive full information about the purpose and conduct of the study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient to receive a replacement defibrillation lead not motivated by an infection and having been informed.\n* Patient who agreed to participate in the study\n* Patients aged 18 years and over\n\nNo Exclusion Criteria'}, 'identificationModule': {'nctId': 'NCT01829269', 'acronym': 'FRAGILE', 'briefTitle': 'French Attitude Registry in Case of ICD Lead Replacement', 'organization': {'class': 'OTHER', 'fullName': 'French Cardiology Society'}, 'officialTitle': 'French Attitude Registry in Case of ICD Lead Replacement', 'orgStudyIdInfo': {'id': '12 759'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with a defibrillator', 'description': 'The study population is that of patients with a defibrillator to have a change of probe.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '92200', 'city': 'Neuilly-sur-Seine', 'country': 'France', 'facility': 'Clinique Ambroise Paré', 'geoPoint': {'lat': 48.8846, 'lon': 2.26965}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'French Cardiology Society', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}