Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2025-12-25 @ 12:14 PM
Study NCT ID:
NCT01401361
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2011-07-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'NOuch@sjm.com', 'phone': '+19497695041', 'title': 'Nancy Ouch', 'organization': 'St. Jude Medical'}, 'certainAgreement': {'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': '150 subjects who met Inc./Excl. criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 received the device. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.', 'eventGroups': [{'id': 'EG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .', 'otherNumAtRisk': 134, 'otherNumAffected': 10, 'seriousNumAtRisk': 134, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'Arrhythmia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 10}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'Congestive Heart Failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Intermittent High Grade AV Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient Ischemic Attack', 'stats': [{'groupId': 'EG000', 'numAtRisk': 134, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '7 days', 'description': 'Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '150 subjects who met Inc/Excl criteria were enrolled. 16 subjects were withdrawn prior to the use of the investigational device, thus,134 were treated. 3 subjects had composite adverse events that were serious and occurred within 7 days of the ablation procedure. These events are part of the primary safety endpoint analysis per protocol.'}, {'type': 'PRIMARY', 'title': 'Primary Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .'}], 'classes': [{'categories': [{'measurements': [{'value': '129', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 minutes', 'description': 'Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '134 subjects were treated with the investigational catheter and system with 1 subject failing to pass the bidirectional block inducibility test 30 minutes post ablation. Thus 133 subjects comprised the primary efficacy cohort.'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .'}], 'classes': [{'categories': [{'measurements': [{'value': '110', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months', 'description': 'Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,\n\n1c, III) during the 3 months post ablation are considered chronic failures.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': '134 subjects were treated with the investigational catheter and system with 10 subjects experiencing recurring AFL. Thus 124 subjects comprised the secondary efficacy cohort (freedom from AFL at 90 days).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '150'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': '16 subjects were withdrawn prior to the use of the investigational device', 'groupId': 'FG000', 'numSubjects': '122'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '16'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Subject/family decision post procedure', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '150', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment Arm', 'description': 'Contact Therapy Cool Path ablation system in conjunction with EnSite Velocity Contact system : The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '82', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64.82', 'spread': '11.97', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '25', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '125', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '140', 'groupId': 'BG000'}]}]}, {'title': 'Canada', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-31', 'studyFirstSubmitDate': '2011-07-21', 'resultsFirstSubmitDate': '2013-11-04', 'studyFirstSubmitQcDate': '2011-07-21', 'lastUpdatePostDateStruct': {'date': '2019-02-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2013-11-04', 'studyFirstPostDateStruct': {'date': '2011-07-25', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Primary Safety:Incidence of Composite, Serious Adverse Events Within 7 Days Post Procedure', 'timeFrame': '7 days', 'description': 'Primary safety is defined as the incidence of composite, serious adverse events within 7 days post-procedure, regardless of whether a determination can be made regarding device relatedness.'}, {'measure': 'Primary Efficacy', 'timeFrame': '30 minutes', 'description': 'Primary efficacy or Acute success is defined as achievement of bidirectional block in the cavo-tricuspid isthmus and non-inducibility of typical atrial flutter at least 30 minutes following the last RF ablation with the investigational system.'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy', 'timeFrame': '3 months', 'description': 'Secondary efficacy / Chronic success is defined as freedom from recurrence of typical atrial flutter 3 months post ablation. Flutter recurrence will be documented on an ECG (or similar such as Holter, telemetry, rhythm strips, etc.). Repeat ablations, new antiarrhythmia medication (Class Ia, Ic, or III) or increase in the dosage of existing anti-arrhythmic medication (Class 1a,\n\n1c, III) during the 3 months post ablation are considered chronic failures.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Typical Atrial Flutter']}, 'descriptionModule': {'briefSummary': 'To demonstrate that the use of Contact Therapy™ Cool Path™ ablation catheter in conjunction with the EnSite Velocity Contact Technology for the treatment of typical atrial flutter\n\n* Does not result into unacceptable risk of intra-procedural composite serious adverse events and,\n* Does not affect efficacy of the ablation procedure The study will also evaluate the', 'detailedDescription': 'This will be a prospective, multi-center and non-randomized study. All enrolled patients who meet the eligibility criteria will receive ablation therapy for typical atrial flutter using the Contact Therapy™ Cool Path™ Cardiac Ablation System. Historical data from published (PMA P060019 Cool Path) , reported (IDE G090109 Cool Path Duo) and published literature on Atrial Flutter RF ablation studies is used to determine performance goals for primary study endpoints and derive the sample size. In addition, the following analyses will be performed in the study\n\n1. Validation of ECI against conventional methods of assessing tip tissue contact and\n2. Ancillary analysis to assess the relationship between the ECI and study outcomes. Subjects will undergo two follow up visits at day 10 and month 3 post procedure. The following assessments will be performed during these visits:\n\n * ECG\n * Query regarding adverse events since the last visit\n * Assessment of anti-arrhythmic and anti-coagulation medication\n * Query regarding recurrence or repeat ablation for typical atrial flutter'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* A signed written Informed Consent\n* Presence of typical atrial flutter (cavo-tricuspid isthmus dependent)\n* If subjects are receiving antiarrhythmic drug therapy (Class I or Class III AAD) for an arrhythmia other than typical atrial flutter, then they need to be controlled on their medication for at least 3 months. If a subject had typical atrial flutter before starting the AAD(s) (Class I or Class III) and then subsequently had another arrhythmia (i.e. atrial fibrillation), then the 3 month AAD criteria will not apply.\n* One documented occurrence of the study arrhythmia documented by ECG, Holter, telemetry strip, or transtelephonic monitor within the past 6 months\n* In good physical health\n* 18 years of age or older\n* Agree to comply with follow-up visits and evaluation\n\nExclusion Criteria:\n\n* Prior typical atrial flutter ablation treatment\n* Pregnancy\n* Atypical flutter or scar flutter (non isthmus dependent)\n* Significant coronary heart disease or heart failure; that is unstable angina pectoris and/or uncontrolled congestive heart failure (NYHA Class III or IV) at the time of enrollment\n* A recent myocardial infarction within 3 months of the intended procedure date\n* Permanent coronary sinus pacing lead\n* Clinically significant tricuspid valvular disease requiring surgery and/or a prosthetic tricuspid heart valve.\n* Evidence of intracardiac thrombus or a history of clotting disorders\n* Participation in another investigational study\n* Cardiac surgery within 1 month prior to the intended procedure date\n* Allergy or contraindication to Heparin'}, 'identificationModule': {'nctId': 'NCT01401361', 'acronym': 'CONTACT_AFL', 'briefTitle': 'Atrial Flutter Ablation With Contact Therapy Cool Path Ablation System Along With EnSite Velocity Contact System', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'Clinical Evaluation of Contact™ Therapy™ Cool Path™ Cardiac Ablation System in Conjunction With EnSite Velocity Contact™ Technology for the Treatment of Typical Atrial Flutter', 'orgStudyIdInfo': {'id': '90064772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment Arm', 'description': 'Atrial Flutter RF Ablation treatment with the Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement.', 'interventionNames': ['Device: Treatment Arm']}], 'interventions': [{'name': 'Treatment Arm', 'type': 'DEVICE', 'otherNames': ['Ablation with Contact Therapy Cool Path system'], 'description': 'The investigational parts of the system consists of Contact Therapy Cool Path ablation catheter, 1500 T9 V1.43 RF Generator, Model 1611 connection cable, EnSite Velocity Contact™ Kit, and EnSite Velocity Contact software controlled via entitlement .', 'armGroupLabels': ['Treatment Arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35211', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Cardiology, P.C.', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '80012', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Aurora Denver Cardiology', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06102', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Hartford Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'zip': '32204', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70121', 'city': 'New Orleans', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Ochsner Medical Center', 'geoPoint': {'lat': 29.95465, 'lon': -90.07507}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Langone Medical Center - Tisch Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'University of Rochester', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27599', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina at Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Presbyterian Hospital', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '43215', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Ohio Health Research Institute - GMC', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97225', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Providence St. Vincent Medical Center', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '18901', 'city': 'Doylestown', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Doylestown Hospital', 'geoPoint': {'lat': 40.31011, 'lon': -75.12989}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Health Research & Education Institute', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Memorial Hermann Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': "St. Luke's Episcopal Hospital", 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '76508', 'city': 'Temple', 'state': 'Texas', 'country': 'United States', 'facility': 'Scott & White Memorial Hospital', 'geoPoint': {'lat': 31.09823, 'lon': -97.34278}}, {'zip': '23229', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Cardiovascular Specialists', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': 'H1T 1C8', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Institut de Cardiologie de Montreal (Montreal Heart Inst.)', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Larry Chinitz, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}