Ignite Creation Date:
2025-12-25 @ 2:02 AM
Ignite Modification Date:
2025-12-27 @ 11:19 PM
Study NCT ID:
NCT01209260
Status:
COMPLETED
Last Update Posted:
2014-02-28
First Post:
2010-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D001281', 'term': 'Atrial Fibrillation'}], 'ancestors': [{'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001145', 'term': 'Arrhythmias, Cardiac'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jonathan.hsu@ucsd.edu', 'phone': '415-476-5706', 'title': 'Jonathan Hsu, MD, MAS', 'organization': 'University of California San Diego'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.', 'description': 'All patients were monitored for both intraprocedural complications and postprocedural complications until discharge. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.', 'eventGroups': [{'id': 'EG000', 'title': 'Radiofrequency Energy Needle (RF)', 'description': 'Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.', 'otherNumAtRisk': 36, 'otherNumAffected': 0, 'seriousNumAtRisk': 36, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Pericardial effusion', 'notes': 'Pericardial effusion detected by intracardiac echocardiography (ICE) after conclusion of the LA ablation procedure, 3 hours after the transseptal puncture.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Transient ischemic attack', 'notes': 'transient ischemic attack with brain magnetic resonance imaging consistent with embolic etiology', 'stats': [{'groupId': 'EG000', 'numAtRisk': 36, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 36, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Transseptal Access Procedure Time', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}, {'id': 'OG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.3', 'groupId': 'OG000', 'lowerLimit': '1.7', 'upperLimit': '3.8'}, {'value': '7.3', 'groupId': 'OG001', 'lowerLimit': '2.7', 'upperLimit': '14.1'}]}]}], 'analyses': [{'pValue': '0.005', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical tests were 2-sided and considered significant if they yielded a p\\<0.05', 'groupDescription': 'Sample size of 72 was targeted to achieve 80% power to detect a 5-minute reduction in transseptal access procedure time (assuming a standard deviation of 7.5 minutes), using a 2-sided alpha of 0.05, with the primary analysis done on an intention-to-treat basis.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Day of procedure', 'description': 'Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.', 'unitOfMeasure': 'minutes', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Adverse Events as a Measure of Safety', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}, {'id': 'OG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Performance of the Assigned Needle Type', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle'}, {'id': 'OG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle'}], 'classes': [{'title': 'Success of assigned needle type', 'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '26', 'groupId': 'OG001'}]}]}, {'title': 'Failure of assigned needle type', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical tests were 2-sided and considered significant if they yielded a p\\<0.05', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'at time of procedure', 'description': 'Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Plastic Dilator Shavings', 'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}, {'units': 'Assigned needles', 'counts': [{'value': '36', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle'}, {'id': 'OG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001'], 'pValueComment': 'Statistical tests were 2-sided and considered significant if they yielded a p\\<0.05.', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'immediately prior to procedure', 'description': 'In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.', 'unitOfMeasure': 'Needles', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Assigned needles', 'denomUnitsSelected': 'Participants', 'populationDescription': 'The assigned needle for each participant was analyzed prior to the procedure'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}, {'id': 'FG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '36'}, {'groupId': 'FG001', 'numSubjects': '36'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Between January 2011 and November 2012, 72 patients were randomized to 1 of 2 transseptal needle groups.', 'preAssignmentDetails': '139 patients were assessed for eligibility; 61 declined to participate, 3 met exclusion criteria, 3 did not enroll for other reasons.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Radiofrequency Energy Needle', 'description': 'Transseptal access using a radiofrequency energy needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}, {'id': 'BG001', 'title': 'Mechanical Needle', 'description': 'Transseptal access using a mechanical (Brockenbrough) needle. Participants for whom puncture failed crossed over to the other intervention; all study analyses were performed on an intention-to-treat basis.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '59.9', 'spread': '11.3', 'groupId': 'BG000'}, {'value': '61.1', 'spread': '11.7', 'groupId': 'BG001'}, {'value': '60.5', 'spread': '11.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '36', 'groupId': 'BG000'}, {'value': '36', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Previous stroke or transient ischemic attack (TIA)', 'classes': [{'title': 'Previous stroke or TIA', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}, {'title': 'No previous stroke or TIA', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Indication for transseptal puncture', 'classes': [{'title': 'Atrial fibrillation', 'categories': [{'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '70', 'groupId': 'BG002'}]}]}, {'title': 'Accessory pathway', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'History of transseptal puncture', 'classes': [{'title': 'Previous transseptal puncture', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '22', 'groupId': 'BG002'}]}]}, {'title': 'No previous transseptal puncture', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '26', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'per protocol'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-01-28', 'studyFirstSubmitDate': '2010-09-09', 'resultsFirstSubmitDate': '2013-12-05', 'studyFirstSubmitQcDate': '2010-09-23', 'lastUpdatePostDateStruct': {'date': '2014-02-28', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2013-12-09', 'studyFirstPostDateStruct': {'date': '2010-09-27', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-01-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Transseptal Access Procedure Time', 'timeFrame': 'Day of procedure', 'description': 'Total amount of procedure time, from the beginning of the transseptal procedure until left atrium (LA) access is obtained in each patient. Participants for whom puncture failed crossed over to the other Intervention. Analysis performed on an intention-to-treat basis.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Adverse Events as a Measure of Safety', 'timeFrame': 'During or immediately after procedure, up to 1 day after procedure. On average, up to 1 day after the procedure.'}, {'measure': 'Performance of the Assigned Needle Type', 'timeFrame': 'at time of procedure', 'description': 'Failure to achieve transseptal access with the assigned needle type resulted in crossover because of an inability to puncture the interatrial septem despite forward pressure and tenting, leading to concern that further effort might lead to perforation of the free (lateral) LA wall.'}, {'measure': 'Plastic Dilator Shavings', 'timeFrame': 'immediately prior to procedure', 'description': 'In ex vivo pre-procedural testing, the assigned transseptal needle was advanced through the plastic dilator and sheath, and the presence of grossly visible plastic shavings after introduction of the needle through the dilator and long sheath was recorded.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Transseptal Puncture', 'Radiofrequency Energy', 'Left Atrium Access', 'Left Atrial Catheterization', 'Ablation', 'Transseptal Catheterization', 'Electrocautery', 'Catheter Ablation', 'Atrial Fibrillation'], 'conditions': ['Heart Diseases']}, 'referencesModule': {'references': [{'pmid': '13649591', 'type': 'BACKGROUND', 'citation': 'ROSS J Jr, BRAUNWALD E, MORROW AG. Transseptal left atrial puncture; new technique for the measurement of left atrial pressure in man. Am J Cardiol. 1959 May;3(5):653-5. doi: 10.1016/0002-9149(59)90347-9. No abstract available.'}, {'pmid': '3943231', 'type': 'BACKGROUND', 'citation': 'B-Lundqvist C, Olsson SB, Varnauskas E. Transseptal left heart catheterization: a review of 278 studies. Clin Cardiol. 1986 Jan;9(1):21-6. doi: 10.1002/clc.4960090105.'}, {'pmid': '7987913', 'type': 'BACKGROUND', 'citation': 'Roelke M, Smith AJ, Palacios IF. The technique and safety of transseptal left heart catheterization: the Massachusetts General Hospital experience with 1,279 procedures. Cathet Cardiovasc Diagn. 1994 Aug;32(4):332-9. doi: 10.1002/ccd.1810320409.'}, {'pmid': '16516090', 'type': 'BACKGROUND', 'citation': 'De Ponti R, Cappato R, Curnis A, Della Bella P, Padeletti L, Raviele A, Santini M, Salerno-Uriarte JA. Trans-septal catheterization in the electrophysiology laboratory: data from a multicenter survey spanning 12 years. J Am Coll Cardiol. 2006 Mar 7;47(5):1037-42. doi: 10.1016/j.jacc.2005.10.046. Epub 2006 Feb 9.'}, {'pmid': '17997362', 'type': 'BACKGROUND', 'citation': 'Bidart C, Vaseghi M, Cesario DA, Mahajan A, Fujimura O, Boyle NG, Shivkumar K. Radiofrequency current delivery via transseptal needle to facilitate septal puncture. Heart Rhythm. 2007 Dec;4(12):1573-6. doi: 10.1016/j.hrthm.2007.07.008. Epub 2007 Jul 14. No abstract available.'}, {'pmid': '11553955', 'type': 'BACKGROUND', 'citation': 'Justino H, Benson LN, Nykanen DG. Transcatheter creation of an atrial septal defect using radiofrequency perforation. Catheter Cardiovasc Interv. 2001 Sep;54(1):83-7. doi: 10.1002/ccd.1244.'}, {'pmid': '19925604', 'type': 'BACKGROUND', 'citation': 'Smelley MP, Shah DP, Weisberg I, Kim SS, Lin AC, Beshai JF, Burke MC, Knight BP. Initial experience using a radiofrequency powered transseptal needle. J Cardiovasc Electrophysiol. 2010 Apr;21(4):423-7. doi: 10.1111/j.1540-8167.2009.01656.x. Epub 2009 Nov 17.'}, {'pmid': '15736263', 'type': 'BACKGROUND', 'citation': 'Sakata Y, Feldman T. Transcatheter creation of atrial septal perforation using a radiofrequency transseptal system: novel approach as an alternative to transseptal needle puncture. Catheter Cardiovasc Interv. 2005 Mar;64(3):327-32. doi: 10.1002/ccd.20284.'}, {'pmid': '20506170', 'type': 'BACKGROUND', 'citation': 'Crystal MA, Mirza MA, Benson LN. A radiofrequency transseptal needle: initial animal studies. Catheter Cardiovasc Interv. 2010 Nov 1;76(5):769-73. doi: 10.1002/ccd.22600.'}, {'pmid': '24045120', 'type': 'DERIVED', 'citation': 'Hsu JC, Badhwar N, Gerstenfeld EP, Lee RJ, Mandyam MC, Dewland TA, Imburgia KE, Hoffmayer KS, Vedantham V, Lee BK, Tseng ZH, Scheinman MM, Olgin JE, Marcus GM. Randomized trial of conventional transseptal needle versus radiofrequency energy needle puncture for left atrial access (the TRAVERSE-LA study). J Am Heart Assoc. 2013 Sep 17;2(5):e000428. doi: 10.1161/JAHA.113.000428.'}]}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial examining whether a mechanical needle versus a needle that uses radiofrequency energy is better at puncturing through a thin wall in the heart (called "transseptal puncture") as measured by procedure time, during an electrical procedure/study of the heart .', 'detailedDescription': 'Transseptal puncture is a commonly performed procedure allowing access to the left atrium for catheter ablation. Historically, a conventional Brockenbrough needle has been used for this procedure to mechanically puncture the fossa ovalis, which has been well described in the literature.1, 2 Although generally safe, serious complications such as perforation of the atrial wall or aorta can occur.3, 4\n\nPrevious studies have evaluated the feasibility and safety of radiofrequency (RF) energy applied to a conventional needle as a technique to access the left atrium, particularly in patients with a repeat procedure, fibrotic septum or aneurysmal septum.5, 6 As a result of this earlier work, a special proprietary device has been designed. The NRG RF needle (Baylis Medical Inc., Montreal, Canada), uses radiofrequency energy emitted from the needle tip to aid in transseptal access. Despite limited literature to support its superiority and safety7-9compared to the conventional approach, the new device has become adopted in some electrophysiology procedures involving a transseptal puncture.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing radiofrequency ablation within the left atrium through a transseptal approach\n* Patients greater than 18 years of age\n\nExclusion Criteria:\n\n* Patients unable to grant informed, written consent'}, 'identificationModule': {'nctId': 'NCT01209260', 'acronym': 'TRAVERSE-LA', 'briefTitle': 'Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access', 'organization': {'class': 'OTHER', 'fullName': 'University of California, San Francisco'}, 'officialTitle': 'Transseptal Needle Versus Radiofrequency Energy for Left Atrial Access (TRAVERSE-LA): A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'MarcusHsu'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Radiofrequency energy needle', 'description': 'Radiofrequency energy needle for transseptal access', 'interventionNames': ['Device: Radiofrequency energy needle']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mechanical needle', 'description': 'Mechanical (Brockenbrough) needle for transseptal access', 'interventionNames': ['Device: Mechanical Needle']}], 'interventions': [{'name': 'Radiofrequency energy needle', 'type': 'DEVICE', 'otherNames': ['Baylis Medical Inc. transseptal needle', 'NRG RF transseptal needle'], 'description': 'Radiofrequency energy needle for transseptal access', 'armGroupLabels': ['Radiofrequency energy needle']}, {'name': 'Mechanical Needle', 'type': 'DEVICE', 'otherNames': ['Brockenbrough Needle'], 'description': 'Mechanical needle for transseptal access', 'armGroupLabels': ['Mechanical needle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California, San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Gregory Marcus, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}, {'name': 'Jonathan Hsu, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, San Francisco'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, San Francisco', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baylis Medical Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}