Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-29 @ 11:21 AM
Study NCT ID:
NCT01223469
Status:
COMPLETED
Last Update Posted:
2019-01-30
First Post:
2010-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
TOCCATA - Touch+™ for Catheter Ablation
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001281', 'term': 'Atrial Fibrillation'}, {'id': 'D013617', 'term': 'Tachycardia, Supraventricular'}], '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'}, {'id': 'D013610', 'term': 'Tachycardia'}, {'id': 'D000075224', 'term': 'Cardiac Conduction System Disease'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Hendrik.Lambert@endosense.com', 'title': 'Hendrik Lambert PhD, VP of Clinical and Regulatory Affairs', 'organization': 'St. Jude Medical/Endosense'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Atrial Fibrillation', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.', 'otherNumAtRisk': 34, 'otherNumAffected': 0, 'seriousNumAtRisk': 34, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'Right-sided Supraventricular Tachycardia', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.', 'otherNumAtRisk': 43, 'otherNumAffected': 0, 'seriousNumAtRisk': 43, 'seriousNumAffected': 1}], 'seriousEvents': [{'term': 'Sinus Bradycardia', 'notes': 'In the SVT arm, the SAE was a sinus bradycardia, followed by pacemaker implantation in a patient treated for atrial flutter with the study device and with a standard ablation catheter for concomitant RA arrhythmias.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Groin Bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Vascular disorders'}, {'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 43, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Subjects With Operative and Post-operative Serious Adverse Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Atrial Fibrillation', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.'}, {'id': 'OG001', 'title': 'Right-sided Supraventricular Tachycardia', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT.'}], 'classes': [{'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '3 months for AF arm; 7 days for the right SVT arm', 'description': 'For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.\n\nFor AF patients 3 months (±2 weeks)following the index procedure.', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Atrial Fibrillation', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.'}, {'id': 'FG001', 'title': 'Right-sided Supraventricular Tachycardia', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '43'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Atrial Fibrillation', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of atrial fibrillation.'}, {'id': 'BG001', 'title': 'Right-sided Supraventricular Tachycardia', 'description': 'Contact force assisted irrigated RF ablation: radiofrequency ablation of SVT'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '25', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '52', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 77}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-28', 'studyFirstSubmitDate': '2010-10-18', 'resultsFirstSubmitDate': '2014-03-24', 'studyFirstSubmitQcDate': '2010-10-18', 'lastUpdatePostDateStruct': {'date': '2019-01-30', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2014-05-07', 'studyFirstPostDateStruct': {'date': '2010-10-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-06-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Subjects With Operative and Post-operative Serious Adverse Events', 'timeFrame': '3 months for AF arm; 7 days for the right SVT arm', 'description': 'For Right SVT patients 7 days (±1 day) following the index procedure or until hospital discharge whichever is longer.\n\nFor AF patients 3 months (±2 weeks)following the index procedure.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Atrial Fibrillation', 'Supraventricular Tachycardia', 'Contact Force', 'RF Ablation', 'Radiofrequency', 'Pulmonary Vein Isolation', 'Paroxysmal Atrial Fibrillation'], 'conditions': ['Atrial Fibrillation', 'Tachycardia, Supraventricular']}, 'referencesModule': {'references': [{'pmid': '22820056', 'type': 'RESULT', 'citation': 'Reddy VY, Shah D, Kautzner J, Schmidt B, Saoudi N, Herrera C, Jais P, Hindricks G, Peichl P, Yulzari A, Lambert H, Neuzil P, Natale A, Kuck KH. The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study. Heart Rhythm. 2012 Nov;9(11):1789-95. doi: 10.1016/j.hrthm.2012.07.016. Epub 2012 Jul 20.'}, {'pmid': '21872560', 'type': 'RESULT', 'citation': 'Kuck KH, Reddy VY, Schmidt B, Natale A, Neuzil P, Saoudi N, Kautzner J, Herrera C, Hindricks G, Jais P, Nakagawa H, Lambert H, Shah DC. A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23. doi: 10.1016/j.hrthm.2011.08.021. Epub 2011 Aug 26.'}], 'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/22820056', 'label': 'Reddy VY, et. al, The relationship between contact force and clinical outcome during radiofrequency catheter ablation of atrial fibrillation in the TOCCATA study.Heart Rhythm. 2012 Nov;9(11):1789-95'}, {'url': 'http://www.ncbi.nlm.nih.gov/pubmed/21872560', 'label': 'Kuck KH, et.al; A novel radiofrequency ablation catheter using contact force sensing: Toccata study. Heart Rhythm. 2012 Jan;9(1):18-23'}]}, 'descriptionModule': {'briefSummary': 'The main objective of this study is to demonstrate the clinical safety of a contact force sensing RF ablation catheter when used for the treatment of supraventricular tachycardia and atrial fibrillation. In addition, the study will characterize the use and value of contact force measurement during ablation, and the long term success (12 months) of the ablation procedure using this technology.', 'detailedDescription': 'Safety: The primary safety endpoint assesses the incidence of procedure or device related SAEs from procedure to 7 (±1) days post-procedure or hospital discharge, whichever is longer, for patients with right-sided SVT or 3 months (±2 weeks) post-procedure for patients with atrial fibrillation. Secondary safety objectives were to demonstrate safety (operative and post-operative complications) over the 12 months post-procedure.\n\nPerformance: The primary performance endpoint is to demonstrate successful catheter deployment, irrigation and ablation at the target area during supra-ventricular cardiac ablation. The secondary performance endpoint is to demonstrate successful and effective contact force reading between catheter tip and heart wall during mapping and ablation at all locations and all angulations.\n\nEfficacy: Secondary effectiveness objectives will consider acute and chronic elimination of the target arrhythmia, the cost-effectiveness of the system and procedure-related parameters'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with right-sided SVT (including: atrioventricular nodal re entry tachycardia \\[AVNRT\\], accessory pathway Wolff Parkinson White \\[WPW\\] syndrome, atrial tachycardia or isthmus-dependent atrial flutter) or paroxysmal atrial fibrillation\n\nExclusion Criteria:\n\n* Recent (within 3 months) cardiac events including myocardial infarction, acute coronary syndrome, percutaneous coronary intervention, or valve or coronary bypass graft surgery\n* Moderate or severe structural heart disease (ventricular dysfunction or valve disease) as demonstrated by transthoracic (TTE) or transesophageal echocardiogram (TEE) of all four chambers of the heart\n* Known cerebrovascular disease, including a history of stroke or transient ischemic attack\n* Left ventricular ejection fraction of \\<35%\n* Previous heart ablation procedure (surgical or catheter) to the target chamber'}, 'identificationModule': {'nctId': 'NCT01223469', 'acronym': 'TOCCATA', 'briefTitle': 'TOCCATA - Touch+™ for Catheter Ablation', 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott Medical Devices'}, 'officialTitle': 'A Prospective Safety, Performance and Preliminary Effectiveness, Multi-centre, Clinical Investigation Using the Irrigated TactiCath™ Percutaneous Ablation Catheter for the Treatment of Supra-Ventricular Tachyarrhythmia Using RF Ablation', 'orgStudyIdInfo': {'id': 'VP-001 147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Atrial Fibrillation', 'interventionNames': ['Device: Contact force assisted irrigated RF ablation']}, {'type': 'EXPERIMENTAL', 'label': 'Right-sided Supraventricular Tachycardia', 'interventionNames': ['Device: Contact force assisted irrigated RF ablation']}], 'interventions': [{'name': 'Contact force assisted irrigated RF ablation', 'type': 'DEVICE', 'otherNames': ['TactiCath®', 'TactiSys®'], 'description': 'radiofrequency ablation of atrial fibrillation or SVT', 'armGroupLabels': ['Atrial Fibrillation', 'Right-sided Supraventricular Tachycardia']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Karl-Heinz Kuck, Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asklepios Klinik St. Georg, Hamburg, Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abbott Medical Devices', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Endosense', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}