Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-21 @ 3:45 AM
Study NCT ID:
NCT02698592
Status:
UNKNOWN
Last Update Posted:
2016-03-03
First Post:
2016-02-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation
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': 'D057785', 'term': 'Catheters'}], 'ancestors': [{'id': 'D004864', 'term': 'Equipment and Supplies'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-03-02', 'studyFirstSubmitDate': '2016-02-29', 'studyFirstSubmitQcDate': '2016-03-02', 'lastUpdatePostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time to get cavo-tricuspid isthmus block', 'timeFrame': 'during the ablation.'}], 'secondaryOutcomes': [{'measure': 'Time of fluoroscopy.', 'timeFrame': 'during the ablation.'}, {'measure': 'Radio frequency application time.', 'timeFrame': 'during the ablation.'}, {'measure': 'Complications.', 'timeFrame': 'within the first 24 hours.', 'description': 'Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.'}, {'measure': 'Recurrence of atrial flutter.', 'timeFrame': 'one year.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['atrial flutter', 'ablation', 'Thermocool SF catheter'], 'conditions': ['Atrial Flutter.']}, 'referencesModule': {'references': [{'pmid': '10449701', 'type': 'BACKGROUND', 'citation': 'Tsai CF, Tai CT, Yu WC, Chen YJ, Hsieh MH, Chiang CE, Ding YA, Chang MS, Chen SA. Is 8-mm more effective than 4-mm tip electrode catheter for ablation of typical atrial flutter? Circulation. 1999 Aug 17;100(7):768-71. doi: 10.1161/01.cir.100.7.768.'}, {'pmid': '10683351', 'type': 'BACKGROUND', 'citation': 'Jais P, Shah DC, Haissaguerre M, Hocini M, Garrigue S, Le Metayer P, Clementy J. Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter. Circulation. 2000 Feb 22;101(7):772-6. doi: 10.1161/01.cir.101.7.772.'}, {'pmid': '12435182', 'type': 'BACKGROUND', 'citation': 'Schreieck J, Zrenner B, Kumpmann J, Ndrepepa G, Schneider MA, Deisenhofer I, Schmitt C. Prospective randomized comparison of closed cooled-tip versus 8-mm-tip catheters for radiofrequency ablation of typical atrial flutter. J Cardiovasc Electrophysiol. 2002 Oct;13(10):980-5. doi: 10.1046/j.1540-8167.2002.00980.x.'}, {'pmid': '12687839', 'type': 'BACKGROUND', 'citation': 'Scavee C, Georger F, Jamart J, Mancini I, Collet B, Blommaert D, De Roy L. Is a cooled tip catheter the solution for the ablation of the cavotricuspid isthmus? Pacing Clin Electrophysiol. 2003 Jan;26(1P2):328-31. doi: 10.1046/j.1460-9592.2003.00043.x.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether the Thermocool SF ® system is at least as effective and safe as regular 8mm catheters and irrigated tip catheters in the treatment of cavo-tricuspid isthmus dependent atrial flutter.', 'detailedDescription': 'The catheter of Biosense Webster Thermocool SF® is characterized by a porous, thin-walled tip allowing a uniform cooling of the catheter tip and so, achieving increased efficiency in cooling. This allows to reduce the flow of irrigation and power output while achieving similar tissue temperatures as the conventional irrigated catheters. There is evidence of greater efficiency of Thermocool SF® catheter in causing tissue damage, but there are no clinical studies on the specific treatment of common atrial flutter.\n\nInvestigators hypothesize that the Thermocool SF® system is at least as effective and safe in the treatment of cavo-tricuspid isthmus dependent atrial flutter as conventional and 8 mm irrigated tip catheters.\n\n150 patients with common atrial flutter were randomized to 3 groups of 50 patients and each group underwent ablation catheter ablation with CelsiusTMDS® 8 mm, 3.5 mm irrigated tip Thermocool® or Thermocool® SF respectively. After the procedure, patients are being followed by clinical reviews, electrocardiograms at the 3rd, 6th and 12th months, 24h ECG-Holter examination at the first and 6th month and monthly phone consultation. Rate of recurrence and presence of other supraventricular arrhythmias are being recorded during follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with symptomatic common atrial flutter.\n* Electrocardiographic documentation of common atrial flutter.\n\nExclusion Criteria:\n\n* Refusal to give consent.\n* Life expectancy less than 6 months.\n* Contraindication for ablation.\n* Previous cavo-tricuspid isthmus ablation.'}, 'identificationModule': {'nctId': 'NCT02698592', 'briefTitle': 'Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Universitario Central de Asturias'}, 'officialTitle': 'Comparative Study to Assess Safety and Efficacy of Catheters CelsiusTMDS® 8 mm, Thermocool® 3.5 mm of Irrigated Tip and Thermocool® SF in the Treatment of Cavo-tricuspid Isthmus Dependent Atrial Flutter', 'orgStudyIdInfo': {'id': '38/2012'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CelsiusTMDS® 8 mm catheter', 'description': '50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.', 'interventionNames': ['Device: CelsiusTMDS® 8 mm catheter']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Thermocool® 3.5 mm irrigated catheter', 'description': '50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.', 'interventionNames': ['Device: Thermocool® 3.5 mm catheter of irrigated tip']}, {'type': 'EXPERIMENTAL', 'label': 'Thermocool® SF catheter', 'description': '50 patients underwent ablation with Thermocool® SF catheter.', 'interventionNames': ['Device: Thermocool® SF catheter']}], 'interventions': [{'name': 'CelsiusTMDS® 8 mm catheter', 'type': 'DEVICE', 'description': 'After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with CelsiusTMDS® 8 mm catheter, until complete isthmic block is achieved.', 'armGroupLabels': ['CelsiusTMDS® 8 mm catheter']}, {'name': 'Thermocool® 3.5 mm catheter of irrigated tip', 'type': 'DEVICE', 'description': 'After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® 3.5 mm catheter of irrigated tip, until complete isthmic block is achieved.', 'armGroupLabels': ['Thermocool® 3.5 mm irrigated catheter']}, {'name': 'Thermocool® SF catheter', 'type': 'DEVICE', 'description': 'After demonstrating cavo-tricuspidal isthmic dependant atrial flutter with a duodecapolar catheter, ablation with continuous tissue lesion will be performed with Thermocool® SF catheter, until complete isthmic block is achieved.', 'armGroupLabels': ['Thermocool® SF catheter']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33011', 'city': 'Oviedo', 'state': 'Principality of Asturias', 'country': 'Spain', 'facility': 'Hospital Universitario Central de Asturias', 'geoPoint': {'lat': 43.36029, 'lon': -5.84476}}], 'overallOfficials': [{'name': 'José Manuel Rubín López, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Universitario Central de Asturias'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Universitario Central de Asturias', 'class': 'OTHER'}, 'collaborators': [{'name': 'Johnson & Johnson', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}