Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation
NCT ID: NCT02698592
Last Updated: 2016-03-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
150 participants
INTERVENTIONAL
2012-01-31
2016-12-31
Brief Summary
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Detailed Description
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Investigators 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.
150 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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CelsiusTMDS® 8 mm catheter
50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.
CelsiusTMDS® 8 mm catheter
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.
Thermocool® 3.5 mm irrigated catheter
50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.
Thermocool® 3.5 mm catheter of irrigated tip
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.
Thermocool® SF catheter
50 patients underwent ablation with Thermocool® SF catheter.
Thermocool® SF catheter
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.
Interventions
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CelsiusTMDS® 8 mm catheter
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.
Thermocool® 3.5 mm catheter of irrigated tip
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.
Thermocool® SF catheter
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.
Eligibility Criteria
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Inclusion Criteria
* Electrocardiographic documentation of common atrial flutter.
Exclusion Criteria
* Life expectancy less than 6 months.
* Contraindication for ablation.
* Previous cavo-tricuspid isthmus ablation.
18 Years
ALL
No
Sponsors
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Johnson & Johnson
INDUSTRY
Hospital Universitario Central de Asturias
OTHER
Responsible Party
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Principal Investigators
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José Manuel Rubín López, PhD
Role: PRINCIPAL_INVESTIGATOR
Hospital Universitario Central de Asturias
Locations
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Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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38/2012
Identifier Type: -
Identifier Source: org_study_id
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