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

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ClinicalTrials.gov Identifier: NCT02088489
Recruitment Status : Completed
First Posted : March 17, 2014
Last Update Posted : August 10, 2017
Sponsor:
Information provided by (Responsible Party):
Josep Lluis Mont Girbau, Hospital Clinic of Barcelona

Study Description
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Brief Summary:
Porous tip catheter use reduces procedure time and RF time in atrial flutter ablation with the same safety.

Condition or disease Intervention/treatment Phase
Atrial Flutter Device: Atrial flutter irrigated catheter Device: Atrial flutter porous tip catheter Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study
Actual Study Start Date : November 2012
Actual Primary Completion Date : February 2015
Actual Study Completion Date : March 2017
Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Time needed to block cavo-tricuspidal isthmus [ Time Frame: During ablation procedure ]

Secondary Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02088489


Locations
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Spain
Hospital Clinic de Barcelona
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Study Chair: Lluis Mont, MD, PhD Hospital Clinic of Barcelona
More Information
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Publications:

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Responsible Party: Josep Lluis Mont Girbau, Head of the Arrhythmia Unit, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02088489    
Other Study ID Numbers: SF vs Tc
First Posted: March 17, 2014    Key Record Dates
Last Update Posted: August 10, 2017
Last Verified: August 2017
Keywords provided by Josep Lluis Mont Girbau, Hospital Clinic of Barcelona:
Atrial flutter
Thermocool catheter
Thermocool SF catheter
Additional relevant MeSH terms:
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Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes