Evaluation of Thermocool SF Catheter on the Common Cavo-tricuspid Isthmus Dependent Atrial Flutter Ablation

Atrial Flutter. Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02698592
• Other study ID #: 38/2012
• Status: Active, not recruiting
• Phase: Phase 4
• First received: February 29, 2016
• Last updated: March 2, 2016
• Start date: January 2012
• Est. completion date: December 2016

Study information

• Verified date: February 2016
• Source: Hospital Universitario Central de Asturias
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 150
• Est. completion date: December 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Atrial Flutter
• Atrial Flutter.

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Universitario Central de Asturias	Oviedo	Principado de Asturias

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Central de Asturias	Johnson & Johnson

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Jaïs P, Shah DC, Haïssaguerre M, Hocini M, Garrigue S, Le Metayer P, Clémenty J. Prospective randomized comparison of irrigated-tip versus conventional-tip catheters for ablation of common flutter. Circulation. 2000 Feb 22;101(7):772-6. — View Citation

Scavée 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(1 Pt 2):328-31. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to get cavo-tricuspid isthmus block		during the ablation.	No
Secondary	Time of fluoroscopy.		during the ablation.	No
Secondary	Radio frequency application time.		during the ablation.	No
Secondary	Complications.	Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.	within the first 24 hours.	Yes
Secondary	Recurrence of atrial flutter.		one year.	No