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

Phase 4

• Conditions: Atrial Flutter.
• Interventions: Device: Thermocool® SF catheter; Device: CelsiusTMDS® 8 mm catheter; Device: Thermocool® 3.5 mm catheter of irrigated tip

• Registration Number: NCT02698592
• Lead Sponsor: Hospital Universitario Central de Asturias

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2015-12
• Status Verified: 2016-02
• Study First Submitted: 2016-02-29
• Study First Submitted QC: 2016-03-02
• Last Update Submitted: 2016-03-02
• Study First Posted: 2016-03-03
• Last Update Posted: 2016-03-03
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 150

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermocool® SF catheter	Thermocool® SF catheter	50 patients underwent ablation with Thermocool® SF catheter.
CelsiusTMDS® 8 mm catheter	CelsiusTMDS® 8 mm catheter	50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.
Thermocool® 3.5 mm irrigated catheter	Thermocool® 3.5 mm catheter of irrigated tip	50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.

Primary Outcome Measures

Name	Time	Method
Time to get cavo-tricuspid isthmus block	during the ablation.

Secondary Outcome Measures

Name	Time	Method
Time of fluoroscopy.	during the ablation.
Radio frequency application time.	during the ablation.
Complications.	within the first 24 hours.	Defined as vascular complications, cardiac tamponade and outbursts by tissue boiling.
Recurrence of atrial flutter.	one year.

Trial Locations

Locations (1)

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Principado de Asturias, Spain