Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation (Cathena)
Primary Purpose
Atrial Flutter
Status
Completed
Phase
Phase 3
Locations
Spain
Study Type
Interventional
Intervention
Atrial flutter irrigated catheter
Atrial flutter porous tip catheter
Sponsored by
About this trial
This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial flutter, Thermocool catheter, Thermocool SF catheter
Eligibility 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
Sites / Locations
- Hospital Clinic de Barcelona
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Atrial flutter, irrigated catheter
Atrial flutter, porous tip catheter
Arm Description
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
Outcomes
Primary Outcome Measures
Time needed to block cavo-tricuspidal isthmus
Secondary Outcome Measures
Radiofrequency time.
Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.
Fluoroscopy time.
Total X-ray time needed to achieve CTI block.
Complications during the procedure.
Survival free from flutter
Proportion of patients not presenting with an atrial flutter recurrence.
Full Information
NCT ID
NCT02088489
First Posted
February 26, 2014
Last Updated
August 9, 2017
Sponsor
Hospital Clinic of Barcelona
1. Study Identification
Unique Protocol Identification Number
NCT02088489
Brief Title
Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation
Acronym
Cathena
Official Title
Effectiveness and Safety of Porous Tip Irrigated Ablation Catheter Versus Conventional Irrigated Catheter in Isthmus Dependent Atrial Flutter Ablation: a Randomized Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
November 2012 (Actual)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atrial Flutter
Keywords
Atrial flutter, Thermocool catheter, Thermocool SF catheter
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Atrial flutter, irrigated catheter
Arm Type
Active Comparator
Arm Description
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® (Biosense Webster, Diamond Bar, CA) irrigated catheter
Arm Title
Atrial flutter, porous tip catheter
Arm Type
Experimental
Arm Description
Patients with isthmus dependent atrial flutter, undergone to catheter ablation with Thermocool® SF(Biosense Webster, Diamond Bar, CA) irrigated catheter
Intervention Type
Device
Intervention Name(s)
Atrial flutter irrigated catheter
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Atrial flutter porous tip catheter
Intervention Description
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 Outcome Measure Information:
Title
Time needed to block cavo-tricuspidal isthmus
Time Frame
During ablation procedure
Secondary Outcome Measure Information:
Title
Radiofrequency time.
Description
Total radiofrequency time needed to achieve cavo-tricuspidus isthmus (CTI) block.
Time Frame
During ablation procedure
Title
Fluoroscopy time.
Description
Total X-ray time needed to achieve CTI block.
Time Frame
During ablation procedure.
Title
Complications during the procedure.
Time Frame
During ablation procedure.
Title
Survival free from flutter
Description
Proportion of patients not presenting with an atrial flutter recurrence.
Time Frame
Up to 12 months after procedure.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lluis Mont, MD, PhD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
8447269
Citation
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Results Reference
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Citation
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Results Reference
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PubMed Identifier
19709510
Citation
Cuesta A, Mont L, Alvarenga N, Rogel U, Brugada J. Comparison of 8-mm-tip and irrigated-tip catheters in the ablation of isthmus-dependent atrial flutter: a prospective randomized trial. Rev Esp Cardiol. 2009 Jul;62(7):750-6. doi: 10.1016/s1885-5857(09)72355-2. English, Spanish.
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Citation
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Citation
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Citation
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Results Reference
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Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation
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