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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
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atrial Flutter focused on measuring Atrial flutter, Thermocool catheter, Thermocool SF catheter

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

First Posted
February 26, 2014
Last Updated
August 9, 2017
Sponsor
Hospital Clinic of Barcelona
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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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PubMed Identifier
22494043
Citation
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PubMed Identifier
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Citation
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PubMed Identifier
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Citation
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Thermocool SF Catheter Versus Thermocool Catheter in Isthmus-dependent Atrial Flutter Ablation

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