Clinical trial NCT02698592: Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Atrial Flutter.
Keywords: atrial flutter
ablation
Thermocool SF catheter
Lead sponsor: Hospital Universitario Central de Asturias
Sponsor class: OTHER
Collaborators: name: Johnson & Johnson
First posted: 2016-03-03
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Patients with symptomatic common atrial flutter.
* Electrocardiographic documentation of common atrial flutter.

Exclusion Criteria:

* Refusal to give consent.
* Life expectancy less than 6 months.
* Contraindication for ablation.
* Previous cavo-tricuspid isthmus ablation.

Primary outcomes:
measure: Time to get cavo-tricuspid isthmus block
timeFrame: during the ablation.
Secondary outcomes:
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.
measure: Recurrence of atrial flutter.
timeFrame: one year.
Other outcomes:
Locations:
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Principado de Asturias
Study officials:
affiliation: Hospital Universitario Central de Asturias
name: José Manuel Rubín López, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.