Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2025-12-26 @ 1:22 AM
Study NCT ID:
NCT03437733
Status:
COMPLETED
Last Update Posted:
2025-06-29
First Post:
2018-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['France']}, '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': 'ClinicalTrialDisclosure@its.jnj.com', 'phone': '844-434-4210', 'title': 'Franchise Medical Director', 'organization': 'Biosense Webster, Inc.'}, 'certainAgreement': {'otherDetails': 'A copy of the manuscript must be provided to the sponsor for review at least 60 days before submission for publication or presentation. If requested in writing, such publication will be withheld for up to an additional 60 days.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Up to 405 Days', 'description': 'The safety population included all participants who have undergone insertion of the study catheter.', 'eventGroups': [{'id': 'EG000', 'title': 'Roll-in Study Phase: RF Ablation', 'description': 'Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Main Study Phase: RF Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).', 'otherNumAtRisk': 87, 'deathsNumAtRisk': 87, 'otherNumAffected': 0, 'seriousNumAtRisk': 87, 'deathsNumAffected': 0, 'seriousNumAffected': 2}], 'seriousEvents': [{'term': 'Major Vascular Access Complication/ Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'ST-elevation myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Lumbar vertebral fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}, {'term': 'Sternal fracture', 'stats': [{'groupId': 'EG000', 'numAtRisk': 8, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 87, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA Version 20.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 90 days (post initial mapping and ablation procedure)', 'description': 'A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.'}, {'type': 'PRIMARY', 'title': 'Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days (post initial mapping and ablation procedure)', 'description': 'A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The population analysis included the modified intent-to-treat (mITT) analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Acute Procedural Success', 'denoms': [{'units': 'Participants', 'counts': [{'value': '82', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '100', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Day 1', 'description': 'Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Population included participants who had the adenosine/isoproterenol challenge.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Individual PAE From Primary Composite', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Death', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Atrio-esophageal fistula', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Myocardial infraction', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Cardiac tamponade/perforation', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Thromboembolism', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Stroke/cerebrovascular accident (CVA)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Transient ischemic attack', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Phrenic nerve paralysis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pulmonary vein stenosis', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Major vascular access complication/bleeding', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)', 'description': 'A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The population analysis included the mITT analysis set included all enrolled participants who met eligibility criteria, had undergone insertion of the study catheters and were followed-up for 90-days period for evaluation of PAEs. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Adverse Device Effects (SADEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 405 Days', 'description': 'An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': '0 - 7 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '8 - 30 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '>= 31 Days', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)', 'description': 'Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Non-serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 405 Days', 'description': 'An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Unscheduled visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)', 'description': 'Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and had post-ablation MRI. Here 'n' (number analyzed) signifies participants with MRI done at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Symptomatic', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Asymptomatic', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 405 Days', 'description': 'Number of participants with symptomatic and asymptomatic cerebral emboli was reported', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With New or Worsening Neurologic Deficits', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Pre-procedure', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '1 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '3 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '6 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-procedure, discharge, 1 Month, 3 Month and 6 Month', 'description': 'Number of participants with new or worsening neurologic deficits was reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Neurological Assessment Evaluable (NAE) Analysis set was a subset of the Per Protocol Population, consented and were eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants with neurological deficit at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With NIHSS Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Pre-procedure: NIHSS Score: 0', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Pre-procedure: NIHSS Score: 1-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-procedure: NIHSS Score: 5-15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-procedure: NIHSS Score: 16-20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Pre-procedure: NIHSS Score: 21-42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge: NIHSS Score: 0', 'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}]}]}, {'title': 'Discharge: NIHSS Score: 1-4', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge: NIHSS Score: 5-15', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge: NIHSS Score: 16-20', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Discharge: NIHSS Score: 21-42', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Pre-procedure and at discharge (Up to 405 Days)', 'description': "The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke).", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With MoCA Scores', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Pre-procedure: 0-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}]}]}, {'title': 'Pre-procedure: 26-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000'}]}]}, {'title': '1 Month: 0-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': '1 Month: 26-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000'}]}]}, {'title': '3 Month: 0-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '3 Month: 26-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '2', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 Month: 0-25', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': '6 Month: 26-30', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 405 Days', 'description': 'Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "NAE Analysis set was a subset of the Per Protocol Population, consent and are eligible for the required neurological assessments, and have post-ablation MRI. Here 'n' (number analyzed) signifies participants analyzed at specified time point."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Hospitalization for Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '87', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': '0 - 7 Days', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': '8 - 30 Days', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': '>= 31 Days', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)', 'description': 'Hospitalization was defined as prolonged stay greater than or equal to (\\>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure \\>= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The safety population was defined to consist of all enrolled participants who have undergone insertion of the study catheter. Here 'n' (number analyzed) signifies the number of participants analyzed at specified timepoints."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '327', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Balloon Catheter Ablation: Left Superior Pulmonary Vein (LSPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Catheter Ablation: Left Inferior Pulmonary Vein (LIPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Catheter Ablation: Right Superior Pulmonary Vein (RSPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Catheter Ablation: Right Inferior Pulmonary Vein (RIPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '98.8', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Catheter Ablation: Right Middle Pulmonary Vein (RMPV)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon Catheter Ablation: Left Pulmonary Vein (LPV)-common', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '100.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: LSPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '76', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: LIPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '75', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: RSPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: RIPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '83', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: RMPV', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '1', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}, {'title': 'Balloon and Focal Catheter Ablation: LPV-common', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1', 'groupId': 'OG000'}]}, {'units': 'PV Veins', 'counts': [{'value': '9', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 405 Days', 'description': 'Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'PV Veins', 'denomUnitsSelected': 'PV Veins', 'populationDescription': "PP analysis set included participants who were enrolled and met all eligibility criteria; had undergone RF ablation with study catheters; and were treated for the study-related arrhythmia. Here 'n' (number analyzed) signifies number of pulmonary veins (PV) in all evaluable participants analyzed at specified category."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers', 'denoms': [{'units': 'Participants', 'counts': [{'value': '85', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 405 Days', 'description': 'Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '84', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Documented AF/AT/AFL', 'categories': [{'measurements': [{'value': '76.2', 'groupId': 'OG000'}]}]}, {'title': 'Documented Symptomatic AF/AT/AFL', 'categories': [{'measurements': [{'value': '81.0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 6 Months', 'description': 'Percentage of participants with six-month arrythmia recurrence \\[defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes \\>30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)\\] was reported.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency (RF) Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'classes': [{'title': 'Documented AF/AT/AFL', 'categories': [{'measurements': [{'value': '65.8', 'groupId': 'OG000'}]}]}, {'title': 'Documented Symptomatic AF/AT/AFL', 'categories': [{'measurements': [{'value': '72.2', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to 12 Months', 'description': 'Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode \\>30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "PP analysis set included participants who comply with the following criteria: a). were enrolled and met all eligibility criteria; b). had undergone RF ablation with study catheters; c) were treated for the study-related arrhythmia. Here 'N' (number of participants analyzed) signifies the number of participants analyzed in this outcome measure."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Roll-in Study Phase: RF Ablation', 'description': 'Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.'}, {'id': 'FG001', 'title': 'Main Study Phase: RF Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '90'}]}, {'type': 'Safety', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}, {'groupId': 'FG001', 'numSubjects': '87'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Eligibility criteria not met', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Roll-in Study Phase: Radiofrequency (RF) Ablation', 'description': 'Roll-in study phase was to demonstrate the acute effectiveness of the multi-electrode RF balloon catheter in the absence of confounding evidence that reflects early stages of a medical device learning curve.'}, {'id': 'BG001', 'title': 'Main Study Phase: RF Ablation', 'description': 'RF ablation was done using multi-electrode radiofrequency balloon catheter device (facilitate electrophysiological mapping of the heart and to transmit RF current to the target tissue) and multi-electrode circular diagnostic catheter device (recording and mapping of the atria of the heart with the carto system).'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '61.9', 'spread': '6.90', 'groupId': 'BG000'}, {'value': '60.2', 'spread': '10.05', 'groupId': 'BG001'}, {'value': '60.3', 'spread': '9.81', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '8', 'groupId': 'BG000'}, {'value': '87', 'groupId': 'BG001'}, {'value': '95', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '31', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '61', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Safety Population included all enrolled participants who have undergone insertion of the study catheter.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-07-20', 'size': 3261791, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-29T05:38', 'hasProtocol': True}, {'date': '2018-10-02', 'size': 3616688, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2020-01-29T05:38', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2019-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-20', 'studyFirstSubmitDate': '2018-02-13', 'resultsFirstSubmitDate': '2020-01-29', 'studyFirstSubmitQcDate': '2018-02-13', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-01-29', 'studyFirstPostDateStruct': {'date': '2018-02-19', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-02-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With Early Onset Primary Adverse Events (PAEs): Death, Atrio-esophageal Fistula and Pulmonary Vein Stenosis', 'timeFrame': 'Up to 90 days (post initial mapping and ablation procedure)', 'description': 'A Primary AEs is an event which occurred within 90 days following initial ablation procedure. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.'}, {'measure': 'Number of Participants With Early Onset PAEs: Myocardial Infraction, Cardiac Tamponade/Perforation, Thromboembolism, Stroke/Cerebrovascular Accident, Transient Ischemic Attack, Phrenic Nerve Paralysis, and Major Vascular Access Complication/Bleeding', 'timeFrame': 'Up to 7 days (post initial mapping and ablation procedure)', 'description': 'A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.'}, {'measure': 'Percentage of Participants With Acute Procedural Success', 'timeFrame': 'Day 1', 'description': 'Acute procedural success is defined as confirmation of entrance block in treated pulmonary veins (PV) after adenosine and/or isoproterenol challenge (with or without the use of a focal catheter).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Individual PAE From Primary Composite', 'timeFrame': 'Up to 7 days for MI, CT/perforation, thromboembolism, stroke/CVA, TIA, PNP and MVAC (initial mapping and ablation procedure) and up to 90 days for death, AE fistula, and PVST (post procedure)', 'description': 'A Primary AEs is an event which occurred within the first week (7 days of the initial mapping and ablation procedure) which included death, atrio-esophageal fistula (AE fistula) and pulmonary vein stenosis (PVST); and up to 90 days post procedure which included myocardial infraction (MI), cardiac tamponade (CT)/perforation, thromboembolism, stroke/cerebrovascular accident (CVA), Transient ischemic attack (TIA), phrenic nerve paralysis (PNP), and major vascular access complication (MVAC)/bleeding following initial ablation procedure.'}, {'measure': 'Number of Participants With Serious Adverse Device Effects (SADEs)', 'timeFrame': 'Up to 405 Days', 'description': 'An adverse device effect is an adverse event related to the to the device and or the procedure of the investigational medical device. SADE is an adverse device effect that has resulted in any of the consequences characteristic of an SAE.'}, {'measure': 'Number of Participants With Serious Non-primary Adverse Events Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and Greater Than or Equal to (>=) 31 Days (Late Onset) of Initial Ablation Procedure', 'timeFrame': 'Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)', 'description': 'Serious non-primary adverse event was defined as SAE that are not primary adverse events. Primary AEs included: Death, atrio-esophageal fistula, and pulmonary vein stenosis.'}, {'measure': 'Number of Participants With Non-serious Adverse Events', 'timeFrame': 'Up to 405 Days', 'description': 'An AE is any untoward medical occurrence in participants whether or not related to the investigational medical device.'}, {'measure': 'Number of Participants With Pre-and Post-ablation Asymptomatic and Symptomatic Cerebral Emboli', 'timeFrame': 'Pre-procedure, at Discharge, 1 Month and at unscheduled visit (Up to 405 Days)', 'description': 'Number of participants with pre-and post-ablation asymptomatic and symptomatic cerebral emboli was reported.'}, {'measure': 'Number of Participants With Symptomatic and Asymptomatic Cerebral Emboli', 'timeFrame': 'Up to 405 Days', 'description': 'Number of participants with symptomatic and asymptomatic cerebral emboli was reported'}, {'measure': 'Number of Participants With New or Worsening Neurologic Deficits', 'timeFrame': 'Pre-procedure, discharge, 1 Month, 3 Month and 6 Month', 'description': 'Number of participants with new or worsening neurologic deficits was reported.'}, {'measure': 'Number of Participants With NIHSS Scores', 'timeFrame': 'Pre-procedure and at discharge (Up to 405 Days)', 'description': "The National Institutes of Health Stroke Scale, or NIH Stroke Scale (NIHSS) is a tool used to objectively quantify the impairment caused by a stroke. The NIHSS is composed of 11 items, each of which scores a specific ability between 0 and 4. For each item, a score of 0 typically indicates normal function in that specific ability, while a higher score is indicative of some level of impairment. The individual scores from each item are summed to calculate a patient's total NIHSS score. The patient's total NIHSS score ranges from 0 (minimum) - 42 (maximum). Score 0 (no stroke symptoms); 1 - 4 (Minor stroke); 5-15 (Moderate stroke); 16-20 (Moderate to severe stroke); and 21-42 (Severe stroke)."}, {'measure': 'Number of Participants With MoCA Scores', 'timeFrame': 'Up to 405 Days', 'description': 'Montreal Cognitive Assessment (MoCA) is used for detecting cognitive impairment, the scores range from 0 to 30. A score of 26 or higher is considered normal, patients with mild cognitive impairment (MCI) were scored an average of 22 and patients with significant cognitive impairment (SCI) were scored an average of 16.'}, {'measure': 'Number of Participants With Hospitalization for Cardiovascular Events', 'timeFrame': 'Within 7 Days (Early Onset), 8-30 Days (Peri-procedural) and >=31 Days (Late Onset) of Initial Ablation Procedure (Up to 405 Days)', 'description': 'Hospitalization was defined as prolonged stay greater than or equal to (\\>=) 2 nights post index procedure or in-patient stay not concurrent with index procedure \\>= 1 calendar day. Hospitalization included cardiovascular events due to any cause post index procedure, regardless of protocol-defined serious/non-serious adverse events (AEs) or not. Hence this data was not contributed in serious Adverse events until met the AE definition.'}, {'measure': 'Percentage of Participants With PVI Touch-up by Balloon and/or Focal Catheter Among All Targeted Veins and by Participants', 'timeFrame': 'Up to 405 Days', 'description': 'Percentage of participants with PVI touch-up by balloon and/or focal catheter among all targeted veins and by participants was reported. Most of the participants were ablated by Balloon catheter only while one participant was ablated with both Balloon and Focal catheters.'}, {'measure': 'Percentage of Participants With Use of Focal Catheter Ablation for Non-PV Triggers', 'timeFrame': 'Up to 405 Days', 'description': 'Percentage of participants with use of focal catheter ablation for non-PV triggers was reported.'}, {'measure': 'Percentage of Participants With Freedom From Documented Atrial Fibrillation (AF), Atrial Tachycardia (AT), or Atypical (Left Side) Atrial Flutter (AFL) Episodes or Documented Symptomatic AF/AT/AFL', 'timeFrame': 'Up to 6 Months', 'description': 'Percentage of participants with six-month arrythmia recurrence \\[defined as freedom from documented symptomatic or asymptomatic atrial fibrillation (AF), atrial tachycardia (AT), or atypical (left side) atrial flutter (AFL) episodes (episodes \\>30 seconds on arrhythmia monitoring device from Day 91 to 180 post the index procedure)\\] was reported.'}, {'measure': 'Percentage of Participants With Freedom From Documented, AF, AT, or Atypical (Left Side) AFL Episodes or Documented Symptomatic AF/AT/AFL', 'timeFrame': 'Up to 12 Months', 'description': 'Twelve-month Arrythmia recurrence is defined as a documented symptomatic or asymptomatic episode \\>30 seconds on an arrhythmia monitoring device between day 91 to 365 post the index procedure.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Radiofrequency Ablation', 'Paroxysmal Atrial Fibrillation'], 'conditions': ['Paroxysmal Atrial Fibrillation']}, 'referencesModule': {'references': [{'pmid': '33450010', 'type': 'DERIVED', 'citation': 'Schilling R, Dhillon GS, Tondo C, Riva S, Grimaldi M, Quadrini F, Neuzil P, Chierchia GB, de Asmundis C, Abdelaal A, Vanderlinden L, Tan T, Ding WY, Gupta D, Reddy VY. Safety, effectiveness, and quality of life following pulmonary vein isolation with a multi-electrode radiofrequency balloon catheter in paroxysmal atrial fibrillation: 1-year outcomes from SHINE. Europace. 2021 Jun 7;23(6):851-860. doi: 10.1093/europace/euaa382.'}]}, 'descriptionModule': {'briefSummary': 'This clinical investigation is a prospective, multicenter, single arm clinical evaluation utilizing the multi-electrode radiofrequency balloon catheter and the multi-electrode circular diagnostic catheter.', 'detailedDescription': 'The objective of this clinical investigation is to assess the safety and acute effectiveness of the multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter when used for the isolation of the pulmonary veins in the treatment of Paroxysmal Atrial Fibrillation (PAF).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Diagnosed with Symptomatic Paroxysmal AF.\n2. Selected for atrial fibrillation (AF) ablation procedure for pulmonary vein isolation.\n3. Able and willing to comply with uninterrupted per-protocol anticoagulation requirements\n4. Age 18-75 years.\n5. Able and willing to comply with all pre-, post- and follow-up testing and requirements.\n6. Signed Patient Informed Consent Form.\n\nExclusion Criteria:\n\n1. AF secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause.\n2. Previous surgical or catheter ablation for AF.\n3. Anticipated to receive ablation outside the PV ostia and Cavo-triscuspid-isthmus (CTI) region\n4. Previously diagnosed with persistent, longstanding AF and/or continuous AF \\> 7 days, or \\> 48 hrs terminated by cardioversion.\n5. Any percutaneous coronary intervention (PCI) within the past 2 months.\n6. Valve repair or replacement and presence of a prosthetic valve.\n7. Any carotid stenting or endarterectomy.\n8. Coronary artery bypass grafting (CABG), cardiac surgery (e.g. ventriculotomy, atriotomy), or valvular cardiac surgical or percutaneous procedure within the past 6 months.\n9. Documented left atrium (LA) thrombus on baseline/pre-procedure imaging.\n10. LA antero posterior diameter \\> 50 mm\n11. Any PV with a diameter ≥ 26 mm\n12. Left Ventricular Ejection Fraction (LVEF) \\< 40%.\n13. Contraindication to anticoagulation (e.g. heparin).\n14. History of blood clotting or bleeding abnormalities.\n15. Myocardial infarction within the past 2 months.\n16. Documented thromboembolic event \\[including transient ischemic attack(TIA)\\] within the past 12 months.\n17. Rheumatic Heart Disease.\n18. Uncontrolled heart failure or New York Heart Association (NYHA) function class III or IV.\n19. Awaiting cardiac transplantation or other cardiac surgery within the next 12 months.\n20. Unstable angina.\n21. Acute illness or active systemic infection or sepsis.\n22. Diagnosed atrial myxoma or interatrial baffle or patch.\n23. Presence of implanted pacemaker or implantable cardioverter defibrillator (ICD).\n24. Significant pulmonary disease, (e.g. restrictive pulmonary disease, constrictive or chronic obstructive pulmonary disease) or any other disease or malfunction of the lungs or respiratory system that produces chronic symptoms.\n25. Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study.\n26. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.\n27. Enrollment in an investigational study evaluating another device, biologic, or drug.\n28. Has known pulmonary vein stenosis.\n29. Presence of intramural thrombus, tumor or other abnormality that precludes vascular access, or manipulation of the catheter.\n30. Presence of an Inferior Vena Cava (IVC) filter\n31. Presence of a condition that precludes vascular access.\n32. Life expectancy or other disease processes likely to limit survival to less than 12 months.\n33. Presenting contra-indication for the devices (e.g. transthoracic echocardiography (TTE), CT, etc.) used in the study, as indicated in the respective instructions for use.\n34. Categorized as a vulnerable population and requires special treatment with respect to safeguards of well-being\n\n Additional exclusion criteria for Neurological Assessment Evaluable (NAE) subjects:\n35. Contraindication to use of contrast agents for MRI such as advanced renal disease, etc. (at PI discretion)\n36. Presence of iron-containing metal fragments in the body\n37. Unresolved pre-existing neurological deficit.'}, 'identificationModule': {'nctId': 'NCT03437733', 'acronym': 'SHINE', 'briefTitle': 'Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosense Webster, Inc.'}, 'officialTitle': 'Multi-electrode Radiofrequency Balloon Catheter Use for the Isolation of the Pulmonary Veins.', 'orgStudyIdInfo': {'id': 'BWI_2017_01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Ablation with Multi-electrode Radiofrequency (RF) Balloon Catheter', 'interventionNames': ['Device: Radiofrequency Ablation']}], 'interventions': [{'name': 'Radiofrequency Ablation', 'type': 'DEVICE', 'description': 'RF ablation using multi-electrode radiofrequency balloon catheter and multi-electrode circular diagnostic catheter', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Prague', 'country': 'Czechia', 'facility': 'Na Homolce Hospital', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'city': 'Bari', 'country': 'Italy', 'facility': 'Ospedale "F. Miulli"', 'geoPoint': {'lat': 41.12066, 'lon': 16.86982}}, {'city': 'Milan', 'country': 'Italy', 'facility': 'Centro Cardiologico Monzino', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Liverpool Heart and Chest Hospital', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'city': 'London', 'country': 'United Kingdom', 'facility': "Bart's Health NHS Trust", 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}