Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation (Cathena)

Hospital Clinic of Barcelona

Status and phase: Completed; Phase 3

Conditions: Atrial Flutter

Treatments: Device: Atrial flutter porous tip catheter; Device: Atrial flutter irrigated catheter

Study type: Interventional

Funder types: Other

Identifiers

NCT02088489

SF vs Tc

Details and patient eligibility

About

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

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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70 participants in 2 patient groups

Atrial flutter, irrigated catheter

Active Comparator group

Description:

Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter

Treatment:

Device: Atrial flutter irrigated catheter

Atrial flutter, porous tip catheter

Experimental group

Description:

Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter

Treatment:

Device: Atrial flutter porous tip catheter