Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2026-02-24 @ 5:03 PM
Study NCT ID:
NCT02217657
Status:
COMPLETED
Last Update Posted:
2021-02-25
First Post:
2014-08-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SmartTouch Catheter for Left Anterior Line - SmarT Line Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}], '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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-23', 'studyFirstSubmitDate': '2014-08-14', 'studyFirstSubmitQcDate': '2014-08-14', 'lastUpdatePostDateStruct': {'date': '2021-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Duration of total RF application until bidirectional conduction block across the anterior line is achieved (including a waiting period of 30 minutes)', 'timeFrame': '30 minutes'}], 'secondaryOutcomes': [{'measure': 'Achievement of primary endpoint (bidirectional conduction block at an anterior line)', 'timeFrame': '6 months', 'description': 'Achievement of primary endpoint (bidirectional conduction block at an anterior line). Procedure Duration. Reduction of local potential amplitude during SR or atrial fibrillation after 60 seconds of ablation. Freedom of any atrial tachyarrhythmia at 7 day holter 3 and 6 months after a single ablation procedure. Freedom of any symptoms of atrial arrhythmias 6 months after ablation (except during blanking period of 6 weeks). Confirmation of gap-freeness in MRI (3-6 months after ablation). Quality of Life (atrial fibrillation symptom checklist und major depression index) pre, 3 and 6 months after Ablation. Safety (bleeding, pericardial effusion, thrombembolic events).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Smart-Touch', 'Contact force'], 'conditions': ['Persistent Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '30320138', 'type': 'DERIVED', 'citation': 'Fichtner S, Wakili R, Rizas K, Siebermair J, Sinner MF, Wiktor T, Lackermair K, Schuessler F, Olesch L, Rainer S, Kaab S, Curta A, Kramer H, Estner HL. Benefit of Contact Force Sensing Catheter Technology for Successful Left Atrial Anterior Line Formation: A Prospective Randomized Trial. Biomed Res Int. 2018 Sep 18;2018:9784259. doi: 10.1155/2018/9784259. eCollection 2018.'}]}, 'descriptionModule': {'briefSummary': 'This prospective, randomized study will investigate, if information of the catheter force during ablation of a left anterior line does reduce total RF application time by prevention of ineffective lesions.', 'detailedDescription': 'Catheter ablation has emerged as a realistic therapeutic option for symptomatic atrial fibrillation (AF).\n\nThe three main techniques described for ablation of persistent AF include pulmonary vein (PV) isolation, ablation based on electrogram analysis, and left atrial (LA) linear lesions.\n\nThe ideal endpoint of linear lesions should be complete electrical block; however, this is technically challenging, time consuming, and potentially hazardous. The ST catheter combined with 3D mapping and navigation software, gives physicians a real-time, objective measure of tip-to-tissue contact force during the catheter ablation procedure and will allow physicians to more safely and effectively treat atrial fibrillation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic atrial fibrillation and additional substrate modification or perimitral flutter\n* Patients with persistent atrial fibrillation\n* Patients with perimitral flutter\n* Patients with recurrence after a circumferential PV isolation procedure\n* Patients with paroxysmal atrial fibrillation and AF episodes lasting \\> 7 days\n* Patients (\\>18 und \\<80 Jahre)\n\nExclusion Criteria:\n\n* moderate to severe valvular heart disease,\n* congenital heart disease\n* reduced left ventricular function (ejection fraction \\<35%)\n* any reversible cause for atrial fibrillation (e.g. hyperthyroidism)\n* intracardiac thrombi documented by transesophageal echocardiography\n* myocardial infarction within 3 months, cardiac surgery in the previous three months'}, 'identificationModule': {'nctId': 'NCT02217657', 'briefTitle': 'SmartTouch Catheter for Left Anterior Line - SmarT Line Study', 'organization': {'class': 'OTHER', 'fullName': 'LMU Klinikum'}, 'officialTitle': '"Bidirectional Conduction Block of Left Atrial Anterior Line in Patients With Left Atrial Ablation - Reduction of RF Applications Using the Thermocool SmartTouch Contact Force Sensing Catheter', 'orgStudyIdInfo': {'id': 'MucM001-13'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'operator informed to contact force', 'description': 'Thermocool Smart Touch Catheter, operator informed to contact force (Biosense Webster)', 'interventionNames': ['Device: Thermocool Smart Touch Catheter']}, {'type': 'EXPERIMENTAL', 'label': 'operator blinded to contact force', 'description': 'Thermocool Smart Touch catheter, operator blinded to contact force information (Biosense Webster)', 'interventionNames': ['Device: Thermocool Smart Touch Catheter']}], 'interventions': [{'name': 'Thermocool Smart Touch Catheter', 'type': 'DEVICE', 'description': 'Physician informed to contact force', 'armGroupLabels': ['operator blinded to contact force', 'operator informed to contact force']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81377', 'city': 'Munich', 'state': 'Bavaria', 'country': 'Germany', 'facility': 'Munich University Clinic, Campus Großhadern', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Heidi Estner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Munich University Clinic, Campus Großhadern'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'LMU Klinikum', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director Interventional Electrophysiology', 'investigatorFullName': 'Heidi Estner', 'investigatorAffiliation': 'LMU Klinikum'}}}}