Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-02-25 @ 5:45 PM
Study NCT ID:
NCT02257060
Status:
COMPLETED
Last Update Posted:
2025-02-03
First Post:
2014-09-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Italy']}, 'conditionBrowseModule': {'meshes': [{'id': 'D001282', 'term': 'Atrial Flutter'}], 'ancestors': [{'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-01-31', 'studyFirstSubmitDate': '2014-09-02', 'studyFirstSubmitQcDate': '2014-10-02', 'lastUpdatePostDateStruct': {'date': '2025-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-10-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety', 'timeFrame': '7 Days', 'description': 'Incidence of early onset (within 7 days of ablation procedure) primary AEs'}, {'measure': 'Acute performance', 'timeFrame': 'This outcome measure will be assessed during the procedure but after 30 minutes (or more) of the initial ablation', 'description': 'Acute procedural success as confirmed complete bidirectional conduction block across the CTI (assess ≥30 min following last RF application)'}], 'secondaryOutcomes': [{'measure': 'Safety', 'timeFrame': 'Until one-month follow-up', 'description': 'Incidence of Serious Adverse Events during follow-up'}, {'measure': 'Acute Efficacy', 'timeFrame': 'Within 30 Days', 'description': 'Right atrial flutter recurrence within 30 days'}, {'measure': 'Procedural data', 'timeFrame': 'During Procedure', 'description': 'Ablation parameters, including:\n\n* Total RF ablation time\n* Temperature\n* Contact Force Procedural time Total fluoroscopy time'}]}, 'conditionsModule': {'keywords': ['Endocardial Ablation', 'Atrial Flutter', 'Cavotricuspid Isthmus'], 'conditions': ['Cavotricuspid Isthmus Dependent Right Atrial Flutter']}, 'descriptionModule': {'briefSummary': 'The Linear II study is a prospective, single center, non-randomized, interventional feasibility study with the purpose of assessing acute safety of the Multi-Electrode Linear Type Ablation Catheter and the performance of the product when used for the treatment of symptomatic CTI (cavotricuspid isthmus) dependent right atrial flutter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* At least one symptomatic episode of typical CTI dependent right atrial flutter documented by 12 lead ECG, Holter monitor, transtelephonic event monitor, telemetry strip, or implanted device.\n* Age 18 years or older.\n\nExclusion Criteria:\n\n* Previous typical CTI dependent right atrial flutter ablation\n* Uncontrolled heart failure or NYHA function class IV\n* MI within the past 2 months\n* Any cardiac surgery (i.e. CABG) within the past 2 months\n* Subjects that have ever undergone valvular cardiac surgical procedure (ie, ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve)\n* Awaiting cardiac transplantation or other cardiac surgery within the next 6 months\n* Documented thromboembolic event (including TIA) within the past 12 months\n* Significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment in this study\n* Active illness or active systemic infection or sepsis\n* Unstable angina\n* History of blood clotting or bleeding abnormalities\n* Contraindication to anticoagulation (eg, heparin or warfarin)\n* Life expectancy less than 6 months\n* Presence of intracardiac thrombus, myxoma, interatrial baffle or patch, tumor or other abnormality that precludes catheter introduction or manipulation\n* Presence of a condition that precludes vascular access\n* Women of child bearing potential whom are pregnant, lactating, or planning to become pregnant during the course of the clinical investigation\n* Currently enrolled in another device, biologics, or drug study\n* Contraindication for use of the investigational catheter, as indicated in the respective Instructions For Use'}, 'identificationModule': {'nctId': 'NCT02257060', 'briefTitle': 'LINEAR II - LME-159 Evaluation of a Multi-Electrode Linear Type Ablation Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'Evaluation of a Multi-Electrode Linear Type Ablation Catheter for Endocardial Ablation of Patients With Right Atrial Flutter', 'orgStudyIdInfo': {'id': 'LINEAR II'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Endocardial Ablation', 'interventionNames': ['Procedure: Endocardial Ablation']}], 'interventions': [{'name': 'Endocardial Ablation', 'type': 'PROCEDURE', 'otherNames': ['Radiofrequency (RF) ablation with the', '- Linear Type Ablation Catheter', '- nMARQ™ Multi-Channel RF Generator with Software V2.4.0', '- Linear Ablation Connection Cable'], 'armGroupLabels': ['Endocardial Ablation']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Massimo Grimaldi', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Miulli Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}