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

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ClinicalTrials.gov Identifier: NCT00750711
Recruitment Status : Unknown
Verified September 2008 by University Hospital, Geneva.
Recruitment status was:  Recruiting
First Posted : September 10, 2008
Last Update Posted : September 16, 2008
Sponsor:
Information provided by:
University Hospital, Geneva

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.

Condition or disease Intervention/treatment Phase
Typical Atrial Flutter Radiofrequency Ablation Irrigated Catheters Procedure: Radiofrequency ablation for atrial flutter by catheters Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters
Study Start Date : March 2008
Estimated Primary Completion Date : January 2010

Arm Intervention/treatment
Experimental: KT,2
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.
Procedure: Radiofrequency ablation for atrial flutter by catheters



Primary Outcome Measures :
  1. Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months [ Time Frame: 6 months ]


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

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): NCT00750711


Contacts
Contact: Dipen DS Shah, professor 0041223727197 dipen.shah@hcuge.ch
Contact: Henri HS Sunthorn, doctor 0041223727194 henri.sunthorn@hcuge.ch

Locations
Switzerland
University Hospital of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Dipen DS Shah, professor    0041223727197    dipen.shah@hcuge.ch   
Principal Investigator: Henri SH Sunthorn, doctor         
University Hospital of Geneva Recruiting
Geneva, Switzerland, 1211
Contact: Dipen DS Shah, professor    0041223727197    dipen.shah@hcuge.ch   
Contact: Henri HS Sunthorn, doctor    0041223727194    henri.sunthorn@hcuge.ch   
Principal Investigator: Henri SH Sunthorn, doctor         
Sponsors and Collaborators
University Hospital, Geneva

Responsible Party: Dipen Shah, University Hospital of Geneva
ClinicalTrials.gov Identifier: NCT00750711     History of Changes
Other Study ID Numbers: Protocole 08-006
First Posted: September 10, 2008    Key Record Dates
Last Update Posted: September 16, 2008
Last Verified: September 2008

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes