Ignite Creation Date:
2025-12-24 @ 9:19 PM
Ignite Modification Date:
2025-12-31 @ 8:26 AM
Study NCT ID:
NCT03772704
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2018-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multicenter Imaging in Lead Extraction Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'targetDuration': '30 Days', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-12-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-17', 'studyFirstSubmitDate': '2018-12-07', 'studyFirstSubmitQcDate': '2018-12-10', 'lastUpdatePostDateStruct': {'date': '2020-11-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Correlation of the presence and degree of fibrosis as determined by ECG gated cardiac CT with the presence and degree of fibrosis determined by ease of extraction sheath advancement', 'timeFrame': '30 days', 'description': 'The presence and degree of fibrosis determined by the ease of extraction sheath advancement will be evaluated in three zones. Zone 1 will be the area before the Superior Vena Cava (SVC), Zone 2 in the SVC and Zone 3 after the SVC'}], 'secondaryOutcomes': [{'measure': 'Percentage of ECG gated CT scans that show fibrosis', 'timeFrame': '30 days', 'description': 'The percentage of ECG gated CT scans will be determined by scans that show little to no SVC (Zone 2) fibrosis, show little to no Zone 1 fibrosis, show little to no Zone 3 fibrosis, cardiac perforation, extravascular lead location'}, {'measure': 'Major complications as defined by Heart Rhythm Society (HRS) 2017 consensus guidelines', 'timeFrame': '30 days', 'description': 'major complications'}, {'measure': 'Minor complications as defined by HRS 2017 consensus guidelines', 'timeFrame': '30 days', 'description': 'minor complications'}, {'measure': 'Mortality', 'timeFrame': '30 days', 'description': 'Death assessed'}, {'measure': 'Procedural outcomes', 'timeFrame': '30 days', 'description': 'Operator ease of extraction (grade 1-5)'}, {'measure': 'Fluoroscopy time', 'timeFrame': '30 days', 'description': 'Fluoroscopy duration of time'}, {'measure': 'Pathological reports from extracted leads', 'timeFrame': '30 days', 'description': 'Pathology reports from extracted leads if available'}, {'measure': 'Hospitalizations directly related to the extraction of leads or procedure related', 'timeFrame': '30 days', 'description': 'Number of hospitalizations related to the extraction of leads or procedure related within 30 days post procedure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Mechanical Complication of Cardiac Electronic Device']}, 'referencesModule': {'references': [{'pmid': '36306341', 'type': 'DERIVED', 'citation': 'Patel D, Vatterott P, Piccini J, Epstein LM, Hakmi S, Syed I, Koweek LM, Bolen M, Schoenhagen P, Tarakji KG, Francis N, Shao M, Wilkoff BL. Prospective Evaluation of the Correlation Between Gated Cardiac Computed Tomography Detected Vascular Fibrosis and Ease of Transvenous Lead Extraction. Circ Arrhythm Electrophysiol. 2022 Nov;15(11):e010779. doi: 10.1161/CIRCEP.121.010779. Epub 2022 Oct 28.'}]}, 'descriptionModule': {'briefSummary': 'The primary objectives of this registry is to correlate the amount of fibrosis as documented on Electrocardiogram (ECG) gated Computed Tomography (CT) scans with ease of advancing sheaths over the leads through the SVC zone during lead extraction.', 'detailedDescription': 'This is a multi-center, prospective, observational registry study which plans to enroll approximately 200 patients referred for Cardiac Implantable Electronic Device(CIED) lead extraction at one of the five study centers. The objective of this study is to determine whether a correlation exists between fibrosis detected on ECG gated cardiac CT and the ease of lead extraction as measured by need for extraction energy. All patients will be followed for 30 days post-lead extraction to assess vital status and re-hospitalizations via phone call'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Referred patients for CIED lead extraction', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Referred for CIED (Cardiac Implantable Electronic Device) lead extraction with at least 1 lead with dwell time greater than one year\n* ≥ 18 years of age\n* Appropriate candidate for chest/cardiac CT with contrast and full lead analysis\n\nExclusion Criteria:\n\n* Atrial fibrillation with uncontrolled rate'}, 'identificationModule': {'nctId': 'NCT03772704', 'acronym': 'MILES', 'briefTitle': 'Multicenter Imaging in Lead Extraction Study', 'organization': {'class': 'OTHER', 'fullName': 'The Cleveland Clinic'}, 'officialTitle': 'Multicenter Imaging in Lead Extraction Study', 'orgStudyIdInfo': {'id': '18-1480'}}, 'contactsLocationsModule': {'locations': [{'zip': '55102', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'United Heart and Vascular Clinic', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '11030', 'city': 'Manhasset', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health', 'geoPoint': {'lat': 40.79788, 'lon': -73.69957}}, {'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Duke University', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '20099', 'city': 'Hamburg', 'country': 'Germany', 'facility': 'Asklepios Klinik St. Georg', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}], 'overallOfficials': [{'name': 'Bruce Wilkoff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The Cleveland Clinic'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Cleveland Clinic', 'class': 'OTHER'}, 'collaborators': [{'name': 'Philips Healthcare', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}