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

Hospital Universitario Central de Asturias

Status and phase: Unknown; Phase 4

Conditions: Atrial Flutter.

Treatments: Device: Thermocool® SF catheter; Device: CelsiusTMDS® 8 mm catheter; Device: Thermocool® 3.5 mm catheter of irrigated tip

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02698592

38/2012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

150 participants in 3 patient groups

CelsiusTMDS® 8 mm catheter

Active Comparator group

Description:

50 patients underwent ablation with CelsiusTMDS® 8 mm catheter.

Treatment:

Device: CelsiusTMDS® 8 mm catheter

Thermocool® 3.5 mm irrigated catheter

Active Comparator group

Description:

50 patients underwent ablation with Thermocool® 3.5 mm catheter of irrigated tip.

Treatment:

Device: Thermocool® 3.5 mm catheter of irrigated tip

Thermocool® SF catheter

Experimental group

Description:

50 patients underwent ablation with Thermocool® SF catheter.

Treatment:

Device: Thermocool® SF catheter