Ignite Creation Date:
2025-12-24 @ 12:46 PM
Ignite Modification Date:
2026-01-09 @ 11:01 AM
Study NCT ID:
NCT03906461
Status:
COMPLETED
Last Update Posted:
2024-08-02
First Post:
2019-03-29
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
LSI (Lesion Index) Workflow Observational Study
Sponsor:
Organization:
Raw JSON
{'hasResults': True, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}], 'ancestors': [{'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'laura.zitellaverbick@abbott.com', 'phone': '16517563101', 'title': 'Clinical Research Scientist', 'organization': 'Abbott'}, 'certainAgreement': {'otherDetails': 'First publication of study results will be made as a joint multi-center publication with investigators from all sites contributing data. Institutions may publish data and results individually from its site after any of the following (1) a multi-center publication is published, (2) no multicenter publication is submitted within eighteen months after closures of the Study at all sites or (3) sponsor confirms in writing there will be no multi-center publication.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'description': 'Per protocol, only device or procedure-related serious adverse events were collected and reported. While defined in the protocol, non-serious and non-related adverse event data was not collected in this study. Determination of whether there was a reasonable possibility that an investigational product or device under investigation caused or contributed to an SAE was determined by the investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 143, 'otherNumAffected': 0, 'seriousNumAtRisk': 143, 'deathsNumAffected': 1, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Cardiac Perforation or Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 143, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Achieved Lesion Index (LSI) Values', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'LSI of Lesions in Anterior Portion of Left Superior Pulmonary Vein', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Posterior Portion of Left Superior Pulmonary Vein', 'categories': [{'measurements': [{'value': '4.8', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Anterior Portion or Left Inferior Pulmonary Vein', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Posterior Portion of Left Inferior Pulmonary Vein', 'categories': [{'measurements': [{'value': '4.7', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Anterior Portion of Right Superior Pulmonary Vein', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Posterior Portion of Right Superior Pulmonary Vein', 'categories': [{'measurements': [{'value': '5.0', 'spread': '1.0', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Anterior Portion of Right Inferior Pulmonary Vein', 'categories': [{'measurements': [{'value': '4.9', 'spread': '1.1', 'groupId': 'OG000'}]}]}, {'title': 'LSI of Lesions in Posterior Portion of Right Inferior Pulmonary Veins', 'categories': [{'measurements': [{'value': '5.1', 'spread': '1.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.', 'unitOfMeasure': 'Lesion Index', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site.'}, {'type': 'SECONDARY', 'title': 'Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '12940', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Duration', 'categories': [{'measurements': [{'value': '14.4', 'spread': '9.3', 'groupId': 'OG000'}]}]}, {'title': 'AutoMark Away Time Parameter', 'categories': [{'measurements': [{'value': '7.1', 'spread': '2.2', 'groupId': 'OG000'}]}]}, {'title': 'AutoMark Min Lesion Time Parameter', 'categories': [{'measurements': [{'value': '3.2', 'spread': '0.9', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including time and AutoMark Time parameters for each lesion. Away time refers to the maximum amount of time the catheter can remain away from the AutoMark region before a new AutoMark will be placed. The AutoMark minimum lesion time refers to the minimum amount of time the catheter tip must remain within the AutoMark region before an AutoMark lesion is placed.', 'unitOfMeasure': 's', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Ensite AutoMark Settings and Characteristics: Average RF Power Delivered', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '12940', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '38.0', 'spread': '8.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion', 'unitOfMeasure': 'W', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Ensite AutoMark Settings and Characteristics: Contact Force', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '12939', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '11.7', 'spread': '7.4', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion', 'unitOfMeasure': 'g', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter', 'denoms': [{'units': 'Participants', 'counts': [{'value': '137', 'groupId': 'OG000'}]}, {'units': 'lesions', 'counts': [{'value': '12940', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '5.7', 'spread': '1.7', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion', 'unitOfMeasure': 'mm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'lesions', 'denomUnitsSelected': 'lesions', 'populationDescription': 'LSI achieved values were not available for all subjects. Data may be missing because the LSI algorithm requires six seconds of force and current data as input to report an LSI value or the case files were not received from the site. The AutoMark settings and characteristics of all lesions in the subjects with LSI data were analyzed.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Acute Electrical Isolation of Pulmonary Veins', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '143', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 minutes after last RF ablation in PV region', 'description': 'Acute electrical isolation of the pulmonary veins (PVs), 20 minutes after the last RF ablation in the PV region. The number of participants with acute electric isolation of all pulmonary veins is reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 7-Day Device or Procedure Related SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'within 7-days of index procedure', 'description': 'Device- or procedure-related SAEs within 7-days of the index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With 12-Month Device or Procedure Related SAEs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'between 7 days and 12-months of index procedure', 'description': 'Device- or procedure-related SAEs within 12-months of index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Freedom From AF/AFL/AT Recurrence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '117', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '112', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'No documented episodes greater than 30 seconds with a 24hour-Holter', 'description': 'Freedom from documented AF/AFL/AT recurrence at 12-months post index ablation, excluding a 90-day blanking period. Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 30 seconds with a 24-hour Holter.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes subjects with 12 Month visit complete and 24-hour Holter data available.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Repeat Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months post index procedure (excluding 90-day blanking period)', 'description': 'Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Required Touch up Ablation in Each Region', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Anterior Portion of Left Superior Vein', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Posterior Portion of left Superior Vein', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Posterior Portion of Left Inferior Vein', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Portion of Left Inferior Vein', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Posterior Portion of Right Superior Vein', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Portion of Right Superior Vein', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Anterior Portion of Right Inferior Vein', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Posterior Portion of Right Inferior Vein', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of procedure', 'description': 'Participants with regions that required touch up ablation.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants in Which Pulmonary Veins Required Touch-up Ablation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Left Superior Vein', 'categories': [{'measurements': [{'value': '11', 'groupId': 'OG000'}]}]}, {'title': 'Left Inferior Vein', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}]}]}, {'title': 'Right Superior Vein', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}]}]}, {'title': 'Right Inferior Vein', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of procedure', 'description': 'Participants that required touch-up ablation of each pulmonary vein (PV).', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants That Required Index Procedure Touch-up Ablations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '34', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'At time of procedure', 'description': 'Participants who required at least one touch-up ablation during the index procedure', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'LSI Achieved Values for Repeat RF Ablations', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': 'NA', 'comment': 'There was an insufficient number of participants with events.', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable', 'description': 'In participants who undergo any repeat RF ablation procedures up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The analysis population would include only those subjects with repeat RF ablation procedures.'}, {'type': 'SECONDARY', 'title': 'Overall Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Total initial PV isolation time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '55.6', 'spread': '31.2', 'groupId': 'OG000'}]}]}, {'title': 'Total time for touch-up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '7.4', 'spread': '7.8', 'groupId': 'OG000'}]}]}, {'title': 'Total non-PV ablation time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '52', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.5', 'spread': '34.7', 'groupId': 'OG000'}]}]}, {'title': 'Total procedure time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '142.5', 'spread': '53.1', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes all subjects for total initial PV isolation time and total procedure time. Total time for touch-up includes those subjects in which touch-up time was reported. Total non-PV ablation time includes those subjects in which non-PV ablation was done and time was reported.'}, {'type': 'SECONDARY', 'title': 'Overall RF Ablation Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Total RF time for initial PVI', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '19.3', 'spread': '9.0', 'groupId': 'OG000'}]}]}, {'title': 'Total touch-up RF time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '2.6', 'spread': '3.3', 'groupId': 'OG000'}]}]}, {'title': 'Total RF time for entire procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '22.1', 'spread': '10.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population included all subjects in which RF energy was delivered. Total touch-up RF time only includes subjects in which touch-up ablation was done during the index procedure.'}, {'type': 'SECONDARY', 'title': 'Overall Fluoroscopy Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '127', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '23.7', 'spread': '20.0', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At time of procedure', 'description': 'Overall fluoroscopy time', 'unitOfMeasure': 'minutes', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes subjects in which fluoroscopy was used during the procedure.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Changes 6-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '140', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Change in overall AFEQT Baseline to 6 months', 'categories': [{'measurements': [{'value': '20.8', 'spread': '21.9', 'groupId': 'OG000'}]}]}, {'title': 'Change in EQ-5D-5L EQ VAS Baseline to 6 months', 'categories': [{'measurements': [{'value': '6.3', 'spread': '15.3', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months post index ablation, compared to baseline scores', 'description': 'Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 6-months post index ablation, compared to baseline scores.\n\nAFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.\n\nEQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes those subjects with quality of life scores assessed at both baseline and 6 months.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Changes 12-Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'title': 'Change in overall AFEQT score from baseline to 12 months', 'categories': [{'measurements': [{'value': '23.8', 'spread': '20.3', 'groupId': 'OG000'}]}]}, {'title': 'Change in EQ-5D-5L EQ VAS from Baseline to 12 months', 'categories': [{'measurements': [{'value': '7.6', 'spread': '14.2', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '12-months post index ablation, compared to baseline scores', 'description': 'Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 12-months post index ablation, compared to baseline scores.\n\nAFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.\n\nEQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis population includes subjects with Quality of Life scores at both baseline and 12 months.'}, {'type': 'SECONDARY', 'title': 'Number of Participants on Antiarrhythmic Drugs', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '52', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12-months', 'description': 'Antiarrhythmic drug use at 12-months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Analysis includes subjects that completed the 12-month visit.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Health Care Utilization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'collected throughout the 12-month follow-up period', 'description': 'Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'periods': [{'title': 'Enrollment to Completed Procedure', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Completed 12-month Follow-up', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '143'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '133'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}]}, {'type': 'Missed Visit', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'TactiCath SE and LSI', 'description': 'Catheter ablation to achieve pulmonary vein isolation using TactiCath SE catheter and the EnSite AutoMark module.\n\nUS only: Operators used their standard metrics for AutoMark. OUS: Operators used LSI as the color metric for AutoMark'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '10.9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '48', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '95', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '97', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '44', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '31', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '91', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '17', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '56', 'groupId': 'BG000'}]}]}, {'title': 'Japan', 'categories': [{'measurements': [{'value': '30', 'groupId': 'BG000'}]}]}, {'title': 'Italy', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Spain', 'categories': [{'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Hypertension', 'classes': [{'categories': [{'measurements': [{'value': '83', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Pacemaker or implantable cardiac monitor', 'classes': [{'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Procedure to occlude or close left atrial appendage', 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'History of other arrhythmia', 'classes': [{'categories': [{'measurements': [{'value': '40', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-04', 'size': 1363882, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-25T13:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 143}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-02', 'completionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-21', 'studyFirstSubmitDate': '2019-03-29', 'resultsFirstSubmitDate': '2022-05-10', 'studyFirstSubmitQcDate': '2019-04-04', 'lastUpdatePostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-02-21', 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Achieved Lesion Index (LSI) Values', 'timeFrame': 'At time of procedure', 'description': 'The primary endpoint is a summary of Lesion Index (LSI) values achieved for radiofrequency ablation catheter lesion formation in different anatomical regions of the heart around the pulmonary veins (PVs). LSI is a proprietary index that combines contact force, radiofrequency duration, and radiofrequency current into a single value to express the gradual growth of lesion formation with increasing LSI values.'}], 'secondaryOutcomes': [{'measure': 'Ensite AutoMark Settings and Characteristics: Time and AutoMark Time Parameters', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including time and AutoMark Time parameters for each lesion. Away time refers to the maximum amount of time the catheter can remain away from the AutoMark region before a new AutoMark will be placed. The AutoMark minimum lesion time refers to the minimum amount of time the catheter tip must remain within the AutoMark region before an AutoMark lesion is placed.'}, {'measure': 'Ensite AutoMark Settings and Characteristics: Average RF Power Delivered', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including average radiofrequency (RF) power delivered for each lesion'}, {'measure': 'Ensite AutoMark Settings and Characteristics: Contact Force', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including contact force for each lesion'}, {'measure': 'Ensite AutoMark Settings and Characteristics: AutoMark Lesion Spacing Parameter', 'timeFrame': 'At time of procedure', 'description': 'Descriptive summary of EnSite AutoMark module software settings and characteristics, including AutoMark Lesion Spacing parameter for each lesion'}, {'measure': 'Number of Participants With Acute Electrical Isolation of Pulmonary Veins', 'timeFrame': '20 minutes after last RF ablation in PV region', 'description': 'Acute electrical isolation of the pulmonary veins (PVs), 20 minutes after the last RF ablation in the PV region. The number of participants with acute electric isolation of all pulmonary veins is reported.'}, {'measure': 'Number of Participants With 7-Day Device or Procedure Related SAEs', 'timeFrame': 'within 7-days of index procedure', 'description': 'Device- or procedure-related SAEs within 7-days of the index procedure'}, {'measure': 'Number of Participants With 12-Month Device or Procedure Related SAEs', 'timeFrame': 'between 7 days and 12-months of index procedure', 'description': 'Device- or procedure-related SAEs within 12-months of index procedure'}, {'measure': 'Number of Participants With Freedom From AF/AFL/AT Recurrence', 'timeFrame': 'No documented episodes greater than 30 seconds with a 24hour-Holter', 'description': 'Freedom from documented AF/AFL/AT recurrence at 12-months post index ablation, excluding a 90-day blanking period. Freedom from AF/AFL/AT recurrence is defined as no documented episodes greater than 30 seconds with a 24-hour Holter.'}, {'measure': 'Number of Participants With Repeat Ablation', 'timeFrame': '12-months post index procedure (excluding 90-day blanking period)', 'description': 'Participants with a repeat ablation up to 12-months post index procedure (excluding 90-day blanking period)'}, {'measure': 'Number of Participants That Required Touch up Ablation in Each Region', 'timeFrame': 'At time of procedure', 'description': 'Participants with regions that required touch up ablation.'}, {'measure': 'Number of Participants in Which Pulmonary Veins Required Touch-up Ablation', 'timeFrame': 'At time of procedure', 'description': 'Participants that required touch-up ablation of each pulmonary vein (PV).'}, {'measure': 'Number of Participants That Required Index Procedure Touch-up Ablations', 'timeFrame': 'At time of procedure', 'description': 'Participants who required at least one touch-up ablation during the index procedure'}, {'measure': 'LSI Achieved Values for Repeat RF Ablations', 'timeFrame': 'up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable', 'description': 'In participants who undergo any repeat RF ablation procedures up to 12-months post index procedure, characterization of LSI achieved values for lesions that resulted in electrically conducting gaps versus those that were durable'}, {'measure': 'Overall Procedure Time', 'timeFrame': 'At time of procedure', 'description': 'Overall procedure time and the subset of time elapsed for: first-pass PVI, any other ablations, and any touch-up ablations'}, {'measure': 'Overall RF Ablation Time', 'timeFrame': 'At time of procedure', 'description': 'Overall RF ablation time and the subset of RF ablation time for: first-pass PVI, any other ablations, and any touch-up ablations'}, {'measure': 'Overall Fluoroscopy Time', 'timeFrame': 'At time of procedure', 'description': 'Overall fluoroscopy time'}, {'measure': 'Quality of Life Changes 6-Month', 'timeFrame': '6 months post index ablation, compared to baseline scores', 'description': 'Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 6-months post index ablation, compared to baseline scores.\n\nAFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.\n\nEQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.'}, {'measure': 'Quality of Life Changes 12-Month', 'timeFrame': '12-months post index ablation, compared to baseline scores', 'description': 'Changes in 5-level EQ-5D (EQ-5D-5L) and AFEQT (Atrial Fibrillation Effect on QualiTy-of-life) quality of life scores at 12-months post index ablation, compared to baseline scores.\n\nAFEQT scores range from 0 (most severe symptoms) to 100 (no limitation or disability). A positive change indicates an improvement in AF condition.\n\nEQ-5D-5L EQ VAS scores range from 0 (worst) to 100 (best). A positive change indicates an improvement.'}, {'measure': 'Number of Participants on Antiarrhythmic Drugs', 'timeFrame': '12-months', 'description': 'Antiarrhythmic drug use at 12-months'}, {'measure': 'Number of Participants With Health Care Utilization', 'timeFrame': 'collected throughout the 12-month follow-up period', 'description': 'Health care utilization (including number of unscheduled hospital outpatient/ER visits and inpatient hospitalizations due to arrhythmias) collected throughout the 12-month follow-up period'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Paroxysmal Atrial Fibrillation']}, 'descriptionModule': {'briefSummary': 'This clinical study is a prospective, multicenter, post-market, single-arm, observational study designed to characterize the usage of the Lesion Index (LSI) with the market-released TactiCath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) in subjects with Paroxysmal Atrial Fibrillation (PAF) in a real-word environment.', 'detailedDescription': 'The primary objective of this study is to characterize LSI achieved values for durable lesion formation using the TactiCath SE catheter in the different anatomical regions around the pulmonary veins (PVs) of the heart during RF ablation for the treatment of drug-refractory paroxysmal atrial fibrillation (PAF)\n\nSecondary objectives of this study are as follows:\n\n* To characterize the use of EnSite Automap and AutoMark module software settings, including LSI threshold (OUS), contact force, time, power, flow, and AutoMark spacing using the TactiCath SE catheter for RF ablation for the treatment of drug-refractory PAF.\n* To characterize LSI achieved values for lesions that reconnected versus those that were durable, both in an acute procedural setting as well as in patients who undergo additional ablations during the 12-month follow-up period after an index RF ablation procedure for the treatment of drug-refractory PAF.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'This clinical investigation will enroll male and female subjects undergoing their first ablation procedure from the documented drug-refractory, paroxysmal atrial fibrillation (PAF) population. Subjects must meet all eligibility criteria and provide written informed consent prior to conducting any investigation-specific procedures not considered standard of care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subject must provide written informed consent prior to any clinical investigation related procedure.\n2. Subject is at least 18 years of age.\n3. Subject is willing and able to comply with the protocol-described evaluations and follow-up schedule.\n4. Subject plans to undergo a pulmonary vein isolation (PVI) procedure due to symptomatic paroxysmal AF using RF ablation.\n5. Subject is refractory or intolerant to at least one class I or class III anti-arrhythmic drug.\n\n * For the purposes of this study, "intolerant" includes either:\n\n 1. Subject attempted the drug at any dose and either the subject or their physician chose to discontinue for any reason.\n 2. Subject was offered the drug and refused to take for any reason.\n\nExclusion Criteria:\n\n1. Previous ablation or surgery in the left atria.\n2. Has an implantable cardiac defibrillator (ICD) (pacemakers without defibrillation capacity are allowable).\n3. Participation in another clinical investigation that may confound the results of this study.\n4. Pregnant or nursing.\n5. Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator\'s opinion, could limit the subject\'s ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.\n6. Life expectancy less than 12 months.'}, 'identificationModule': {'nctId': 'NCT03906461', 'briefTitle': 'LSI (Lesion Index) Workflow Observational Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'LSI (Lesion Index) Workflow Post-Market Observational Study', 'orgStudyIdInfo': {'id': 'ABT-CIP-10276'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Radiofrequency Ablation', 'type': 'DEVICE', 'description': 'The Tacticath Contact Force Ablation Catheter, Sensor Enabled (TactiCath SE) is designed to facilitate electrophysiological mapping of the heart chambers and to transmit radiofrequency (RF) current to the catheter tip electrode for intracardiac ablation purposes.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94010', 'city': 'Burlingame', 'state': 'California', 'country': 'United States', 'facility': 'Mills-Peninsula Medical Center', 'geoPoint': {'lat': 37.5841, 'lon': -122.36608}}, {'zip': '46260', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'St. Vincent Hospital', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '38801', 'city': 'Tupelo', 'state': 'Mississippi', 'country': 'United States', 'facility': 'North Mississippi Medical Center', 'geoPoint': {'lat': 34.25807, 'lon': -88.70464}}, {'zip': '11219', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'Maimonides Medical Center', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '44137', 'city': 'Dortmund', 'country': 'Germany', 'facility': 'St. Johannes Hospital', 'geoPoint': {'lat': 51.51494, 'lon': 7.466}}, {'zip': '32032', 'city': 'Feltre', 'country': 'Italy', 'facility': 'Ospedale Santa Maria del Prato', 'geoPoint': {'lat': 46.02085, 'lon': 11.90031}}, {'zip': '113-8510', 'city': 'Bunkyō-Ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Tokyo Medical and Dental University Hospital of Medicine'}, {'zip': '125-8506', 'city': 'Katsushikachō', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'The Jikei University Katsushika Medical Center'}, {'city': 'Boadilla del Monte', 'country': 'Spain', 'facility': 'Hospital Universitario de Monteprincipe', 'geoPoint': {'lat': 40.405, 'lon': -3.87835}}], 'overallOfficials': [{'name': 'Kristen Ruffner, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'EP Program Director'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'TBD via publication plan'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}