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

August 9, 2017 updated by: Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic de Barcelona

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Atrial flutter, irrigated catheter
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
Device: Atrial 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
Experimental: 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
Device: Atrial 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time needed to block cavo-tricuspidal isthmus
Time Frame: During ablation procedure
During ablation procedure

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Clinic of Barcelona

Investigators

  • Study Chair: Lluis Mont, MD, PhD, Hospital Clinic of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2012

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

March 1, 2017

Study Registration Dates

First Submitted

February 26, 2014

First Submitted That Met QC Criteria

March 13, 2014

First Posted (Estimate)

March 17, 2014

Study Record Updates

Last Update Posted (Actual)

August 10, 2017

Last Update Submitted That Met QC Criteria

August 9, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF vs Tc

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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