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Completed

NCT Number: NCT02088489

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

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

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Key information

Conditions

Atrial Flutter Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Atrial flutter irrigated catheter

Device

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

Atrial flutter porous tip catheter

Device

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

Primary outcomes

  1. Time needed to block cavo-tricuspidal isthmus

    Time frame: During ablation procedure

Secondary outcomes

  1. Radiofrequency time.

    Time frame: During ablation procedure

    Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.

  2. Fluoroscopy time.

    Time frame: During ablation procedure.

    Total X-ray time needed to achieve CTI block.

  3. Complications during the procedure.

    Time frame: During ablation procedure.

  4. Survival free from flutter

    Time frame: Up to 12 months after procedure.

    Proportion of patients not presenting with an atrial flutter recurrence.

Sponsors and collaborators

Lead sponsor

Hospital Clinic of Barcelona

Other

Registry information

Official study title

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

Acronym: Cathena

Important dates

Study start
2012
Primary completion
2015
Study completion
2017
First posted
Mar 17, 2014
Registry last updated
Aug 10, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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