Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-03 @ 12:26 PM
Study NCT ID:
NCT02490033
Status:
COMPLETED
Last Update Posted:
2019-08-08
First Post:
2015-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The VERISMART Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001282', 'term': 'Atrial Flutter'}], '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': 'D017115', 'term': 'Catheter Ablation'}], 'ancestors': [{'id': 'D000078703', 'term': 'Radiofrequency Ablation'}, {'id': 'D000078702', 'term': 'Radiofrequency Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2018-10-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-08-06', 'studyFirstSubmitDate': '2015-05-18', 'studyFirstSubmitQcDate': '2015-07-02', 'lastUpdatePostDateStruct': {'date': '2019-08-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to achieve bi-directional block', 'timeFrame': 'up to 60 Seconds', 'description': 'Time to achieve bi-directional block (secs) . This is defined as the time from the first lesion to the time that consistent (\\< one minute) bidirectional block is achieved.\n\nTotal RF energy required for the whole procedure (sec), and total energy required for ablation (power x ablation time in secs).'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Atrial Flutter']}, 'referencesModule': {'references': [{'pmid': '30943196', 'type': 'RESULT', 'citation': "Begg GA, O'Neill J, Sohaib A, McLean A, Pepper CB, Graham LN, Hogarth AJ, Page SP, Gillott RG, Hill N, Walshaw J, Schilling RJ, Kanagaratnam P, Tayebjee MH. Multicentre randomised trial comparing contact force with electrical coupling index in atrial flutter ablation (VERISMART trial). PLoS One. 2019 Apr 3;14(4):e0212903. doi: 10.1371/journal.pone.0212903. eCollection 2019."}]}, 'descriptionModule': {'briefSummary': 'Catheter ablation is now routinely used in the management of heart rhythm disorders. One of the problems with the approach is that it has not been possible to determine whether the ablation catheter is in direct contact with the heart tissue or not. This is important because too much contact has safety implications and too little means that the therapy will be ineffective. Recently two different technologies have been developed to determine contact. Currently it is not know if one is superior to the other, and the objective of this trial is to determine whether there is a difference when treating a rhythm called atrial flutter.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years\n* Documented paroxysmal or persistent atrial flutter\n\nExclusion Criteria:\n\n* Inability or unwillingness to receive oral anticoagulation\n* Previous ablation procedure for AFL\n* Unwillingness or inability to complete the required follow up arrangements\n* Concomitant atrial fibrillation'}, 'identificationModule': {'nctId': 'NCT02490033', 'acronym': 'VERISMART', 'briefTitle': 'The VERISMART Trial', 'organization': {'class': 'OTHER', 'fullName': 'The Leeds Teaching Hospitals NHS Trust'}, 'officialTitle': 'Randomised Trial Comparing Conventional Versus Contact Force and Electrical Coupling Index in Atrial Flutter Ablation', 'orgStudyIdInfo': {'id': 'CD13/11009'}, 'secondaryIdInfos': [{'id': '14/YH/0038', 'type': 'OTHER', 'domain': 'Research Ethics Committee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Contact force unblinded', 'interventionNames': ['Device: Ablation Catheter']}, {'type': 'OTHER', 'label': 'Contact force blinded', 'interventionNames': ['Device: Ablation Catheter']}, {'type': 'OTHER', 'label': 'ECI unblinded', 'interventionNames': ['Device: Ablation Catheter']}, {'type': 'OTHER', 'label': 'ECI blinded', 'interventionNames': ['Device: Ablation Catheter']}], 'interventions': [{'name': 'Ablation Catheter', 'type': 'DEVICE', 'armGroupLabels': ['Contact force blinded', 'Contact force unblinded', 'ECI blinded', 'ECI unblinded']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'LS1 3HE,', 'city': 'Leeds', 'country': 'United Kingdom', 'facility': 'Leeds Teaching Hospitals NHS Trust', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Leeds Teaching Hospitals NHS Trust', 'class': 'OTHER'}, 'collaborators': [{'name': 'Biosense Webster, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}