Ignite Creation Date:
2025-12-24 @ 3:07 PM
Ignite Modification Date:
2026-01-01 @ 7:08 PM
Study NCT ID:
NCT00950092
Status:
TERMINATED
Last Update Posted:
2014-04-03
First Post:
2009-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2009-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-04-02', 'studyFirstSubmitDate': '2009-07-29', 'studyFirstSubmitQcDate': '2009-07-30', 'lastUpdatePostDateStruct': {'date': '2014-04-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary effectiveness endpoint will be assessed as number of subjects free from AF and free of all Class I and III Anti Arrhythmic Drugs (AADs) through 9 months post procedure.', 'timeFrame': '9 months'}], 'secondaryOutcomes': [{'measure': 'Secondary effectiveness endpoint: Proportion of subjects free from AF regardless of their Class I and III AADs status through 9 months post procedure.', 'timeFrame': '9 months'}, {'measure': 'Secondary effectiveness endpoint: Proportion of subjects free of AF/ AFL / AT and off all Class I and Class III AADs.', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['AF', 'atrial fibrillation', 'ablation', 'surgical ablation', 'afib', 'coagulation', 'RF', 'epicardial', 'Arrhythmias'], 'conditions': ['Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This is a multi center, non-randomized, prospective, open label, clinical trial evaluating the safety and efficacy of the nContact Surgical Numeris-AF Tethered Coagulation System when used to treat patients with persistent and longstanding persistent AF during concomitant cardiac surgery.', 'detailedDescription': 'The purpose of this study is to determine the safety and efficacy of the Numeris-AF Tethered Coagulation System with VisiTrax when used to treat persistent and longstanding persistent Atrial Fibrillation(AF)during concomitant cardiac surgery.'}, '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 =\\< 6.0 cm\n* Documented persistent or longstanding persistent AF\n* History of AF =\\< 10 years\n* Scheduled for a concomitant cardiac procedure\n\n * Coronary bypass surgery (CABG)\n * Mitral valve repair/replacement\n * Aortic valve replacement\n * ASD repair\n * Tricuspid valve repair/replacement\n * Myxoma\n * Any combination of the above procedures\n* Provided written informed consent\n\nExclusion Criteria:\n\n* Left atrial size \\> 6.0 cm (pre-op TTE - parasternal 4 chamber view)\n* History of AF \\> 10 years\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* History of coagulopathy\n* Patients who are contraindicated for anticoagulants(heparin, warfarin etc.)\n* Previous cardiac surgery\n* History of pericarditis\n* Previous cerebrovascular accident (CVA)\n* Patients who have active infection or sepsis\n* Patients who have uncorrected reversible cause(s) of AF such as hyperthyroidism and electrolyte imbalance\n* Patients who are being treated for ventricular arrhythmias\n* Patients who have had a previous catheter ablation for AF (does not include ablation for Aflutter)\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': 'NCT00950092', 'briefTitle': 'nContactSurgical Numeris-AF Tethered Coagulation System for Treatment of Persistent & LSP AF', 'organization': {'class': 'INDUSTRY', 'fullName': 'nContact Surgical Inc.'}, 'officialTitle': 'Numeris-AF Tethered Coagulation System With VisiTrax Indicated For Treatment of Persistent and Longstanding Persistent Atrial Fibrillation', 'orgStudyIdInfo': {'id': 'VAL-1116(C)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Treatment', 'interventionNames': ['Device: Numeris-AF Tethered Coagulation System with VisiTrax']}], 'interventions': [{'name': 'Numeris-AF Tethered Coagulation System with VisiTrax', 'type': 'DEVICE', 'otherNames': ['RF Ablation', 'Coagulation of cardiac tissue', 'nContact Surgical'], 'description': 'Surgical radiofrequency (RF) epicardial ablation using the nContact Numeris-AF Tethered Coagulation System', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34285-3298', 'city': 'Venice', 'state': 'Florida', 'country': 'United States', 'facility': 'Venice Regional Medical Center', 'geoPoint': {'lat': 27.09978, 'lon': -82.45426}}, {'zip': '38120', 'city': 'Memphis', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Baptist Memorial Hospital', 'geoPoint': {'lat': 35.14953, 'lon': -90.04898}}], 'overallOfficials': [{'name': 'Edward Garrett, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Baptist Memorial Hospital - Memphis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'nContact Surgical Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}