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Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

Primary Purpose

Typical Atrial Flutter, Radiofrequency Ablation, Irrigated Catheters

Status
Unknown status
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Radiofrequency ablation for atrial flutter by catheters
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Typical Atrial Flutter

Eligibility Criteria

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

Inclusion Criteria:

  • All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter

Exclusion Criteria:

  • Pregnancy
  • Hemodynamic instability
  • A recurrence of previous ablated typical atrial flutter

Sites / Locations

  • University Hospital of GenevaRecruiting
  • University Hospital of GenevaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

KT,2

Arm Description

There are two arms in this study: KT2 arm and KT4 arm. Patients in KT2 arm will be ablated with the 2 mm irrigated catheter and patients in KT4 mm will be ablated with the 4 mm irrigated catheter.

Outcomes

Primary Outcome Measures

Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months

Secondary Outcome Measures

Full Information

First Posted
September 9, 2008
Last Updated
September 15, 2008
Sponsor
University Hospital, Geneva
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1. Study Identification

Unique Protocol Identification Number
NCT00750711
Brief Title
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
Official Title
Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
Study Type
Interventional

2. Study Status

Record Verification Date
September 2008
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
January 2010 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to compare the efficacy of 4 mm irrigated catheters with 2 mm irrigated catheters for ablation of typical flutter.It's a prospective randomised multicenter study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Typical Atrial Flutter, Radiofrequency Ablation, Irrigated Catheters

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
KT,2
Arm Type
Experimental
Arm Description
There are two arms in this study: KT2 arm and KT4 arm. Patients in KT2 arm will be ablated with the 2 mm irrigated catheter and patients in KT4 mm will be ablated with the 4 mm irrigated catheter.
Intervention Type
Procedure
Intervention Name(s)
Radiofrequency ablation for atrial flutter by catheters
Primary Outcome Measure Information:
Title
Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients above the age 18 years undergoing a first catheter ablation for typical atrial flutter Exclusion Criteria: Pregnancy Hemodynamic instability A recurrence of previous ablated typical atrial flutter
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dipen DS Shah, professor
Phone
0041223727197
Email
dipen.shah@hcuge.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Henri HS Sunthorn, doctor
Phone
0041223727194
Email
henri.sunthorn@hcuge.ch
Facility Information:
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dipen DS Shah, professor
Phone
0041223727197
Email
dipen.shah@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Henri SH Sunthorn, doctor
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dipen DS Shah, professor
Phone
0041223727197
Email
dipen.shah@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Henri HS Sunthorn, doctor
Phone
0041223727194
Email
henri.sunthorn@hcuge.ch
First Name & Middle Initial & Last Name & Degree
Henri SH Sunthorn, doctor

12. IPD Sharing Statement

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Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

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