Ignite Creation Date:
2025-12-24 @ 12:55 PM
Ignite Modification Date:
2026-01-02 @ 4:44 AM
Study NCT ID:
NCT01103661
Status:
TERMINATED
Last Update Posted:
2014-04-03
First Post:
2010-04-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-04', 'completionDateStruct': {'date': '2013-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2010-04-13', 'studyFirstSubmitQcDate': '2010-04-14', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-04-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'AF free, off all Class I and III Anti Arrhythmic Drugs (AADs)', 'timeFrame': '12 months', 'description': 'The primary efficacy data will be an evaluation of the number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) from 3 months through 12 months post procedure.'}], 'secondaryOutcomes': [{'measure': 'AF free regardless of the Class I and III AADs status', 'timeFrame': '12 months', 'description': 'The secondary efficacy data will be an assessment of the number of subjects free from AF regardless of their Class I and III AADs status from 3 months through 12 months post procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Longstanding Persistent Atrial Fibrillation', 'AF', 'Chronic AF', 'RF Ablation', 'nContact Surgical', 'Therapy Cool Path Ablation Catheter', 'St. Jude Medical'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, prospective open label, feasibility study evaluating the safety and efficacy of the combined ablation procedure for the treatment of longstanding persistent atrial fibrillation.', 'detailedDescription': 'The purpose of this feasibility study is to evaluate the safety and efficacy of the epicardial / endocardial combined procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially to treat longstanding persistent Atrial Fibrillation (AF) patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\> 18 years; \\< 80 years\n* Left atrium less than or equal to 6.5 cm (TTE)\n* History of AF for less than or equal to 10 years\n* Provided written informed consent\n* Symptomatic longstanding persistent Atrial Fibrillation (AF).\n\nExclusion Criteria:\n\n* Patients requiring concomitant surgery\n* Left ventricular ejection fraction \\< 30%\n* Pregnant or planning to become pregnant during study\n* Co-morbid medical conditions that limit one year life expectancy\n* Measured left ventricular wall thickness \\> 1.5 cm\n* History of coagulopathy\n* Previous cardiac surgery\n* History of pericarditis\n* Previous cerebrovascular accident (CVA), excluding fully resolved TIA\n* Patients who have active infection or sepsis\n* Patients who have uncorrected reversible cause(s) of AF\n* Patients who are contraindicated for anticoagulants\n* Patients who are being treated for arrhythmias other than AF\n* Patients who have had any previous AF or left atrial catheter ablation\n* Current participation in another clinical investigation of a medical device or a drug, or recent participation in such a study within 30 days prior to study enrollment\n* Not competent to legally represent him or herself (e.g., requires a guardian or caretaker as a legal representative).'}, 'identificationModule': {'nctId': 'NCT01103661', 'acronym': 'CAPstopsLSPAF', 'briefTitle': 'Safety and Efficacy Study of The Combined Ablation Procedure To Treat Longstanding Persistent Atrial Fibrillation', 'organization': {'class': 'INDUSTRY', 'fullName': 'nContact Surgical Inc.'}, 'officialTitle': 'Feasibility Study For Safety and Efficacy Evaluation Of The Combined Ablation Procedure For The Treatment Of LongStanding Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'VAL-1140'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Numeris-AF Guided Coagulation System', 'interventionNames': ['Device: Numeris®-AF Guided Coagulation System with VisiTrax®']}], 'interventions': [{'name': 'Numeris®-AF Guided Coagulation System with VisiTrax®', 'type': 'DEVICE', 'description': 'Combined epicardial / endocardial procedure using the nContact Numeris®-AF Guided Coagulation System with VisiTrax® epicardially and the St. Jude Medical Therapy™ Cool Path™ Ablation Catheter endocardially.', 'armGroupLabels': ['Numeris-AF Guided Coagulation System']}]}, 'contactsLocationsModule': {'locations': [{'zip': '46250', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'The Care Group, St Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': "Texas Cardiac Arrhythmia Institute, St. David's Hospital", 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '23225', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Cardiothoracic Surgical Associates, CJW Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nContact Surgical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}