Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

Phase 3

Completed

• Conditions: Atrial Flutter
• Interventions: Device: Atrial flutter porous tip catheter; Device: Atrial flutter irrigated catheter

• Registration Number: NCT02088489
• Lead Sponsor: Hospital Clinic of Barcelona

Brief Summary

Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

Detailed Description

New porous tip catheters appear more effective in atrial fibrillation ablation than conventional irrigated catheter, with the same safety. We could hypothesize porous tip irrigated catheters are more effective than conventional irrigated catheter, reducing procedure time and RF ablation time.We realize a randomized comparison study.

For that, 70 patients with an indication for isthmus-dependent atrial flutter ablation will be randomized to conventional irrigated catheter ablation or porous tip irrigated catheter ablation. A ECG-Holter examination will be done at 1 month follow up after catheter ablation, 6 and 12 months.

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2014-02-26
• Study First Submitted QC: 2014-03-13
• Study First Posted: 2014-03-17
• Primary Completion: 2015-02
• Study Completion: 2017-03
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-09
• Last Update Posted: 2017-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

• All patients undergone to cti-dependent atrial flutter ablation.

Exclusion Criteria

• Left atrial flutter or atrial fibrillation
• Femoral venous access not available.
• Anticoagulation not therapeutic in patients at high thrombo-embolic risk
• Other contraindications to radiofrequency ablations: pregnancy, malignancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Atrial flutter, porous tip catheter	Atrial flutter porous tip catheter	Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
Atrial flutter, irrigated catheter	Atrial flutter irrigated catheter	Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter

Primary Outcome Measures

Name	Time	Method
Time needed to block cavo-tricuspidal isthmus	During ablation procedure

Secondary Outcome Measures

Name	Time	Method
Radiofrequency time.	During ablation procedure	Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.
Fluoroscopy time.	During ablation procedure.	Total X-ray time needed to achieve CTI block.
Complications during the procedure.	During ablation procedure.
Survival free from flutter	Up to 12 months after procedure.	Proportion of patients not presenting with an atrial flutter recurrence.

Trial Locations

Locations (1)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain