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

Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02088489

Acronym

Cathena

Enrollment

Registered

2014-03-17

Start date

2012-11-30

Completion date

2017-03-31

Last updated

2017-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atrial Flutter

Keywords

Atrial flutter, Thermocool catheter, Thermocool SF catheter

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.

Interventions

DEVICEAtrial flutter irrigated catheter

A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with conventional irrigated Thermocool® (Biosense Webster, Diamond Bar, CA) catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation

DEVICEAtrial flutter porous tip catheter

A duodecapolar isthmic curve catheter will be introduced to demonstrate cavo-tricuspidal bidirectional block. We performed atrial flutter ablation with Porous tip Thermocool® SF(Biosense Webster, Diamond Bar, CA)irrigated catheter Continuous lesions from tricuspidal annulus to inferior vena cava will be realized and then complete isthmic block will be confirmed by bidirectional stimulation

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
Time needed to block cavo-tricuspidal isthmus	During ablation procedure

Secondary

Measure	Time frame	Description
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.
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.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026