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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified September 2008 by University Hospital, Geneva.
Recruitment status was:  Recruiting
Information provided by:
University Hospital, Geneva Identifier:
First received: September 9, 2008
Last updated: September 15, 2008
Last verified: September 2008
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 Intervention
Typical Atrial Flutter
Radiofrequency Ablation
Irrigated Catheters
Procedure: Radiofrequency ablation for atrial flutter by catheters

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Typical Flutter Ablation:A Comparison of 4 mm Versus 2 mm Irrigated cathéters

Further study details as provided by University Hospital, Geneva:

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

Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00750711

University Hospital of Geneva
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
  More Information

Responsible Party: Dipen Shah, University Hospital of Geneva Identifier: NCT00750711     History of Changes
Other Study ID Numbers: Protocole 08-006 
Study First Received: September 9, 2008
Last Updated: September 15, 2008

Additional relevant MeSH terms:
Atrial Flutter
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes processed this record on February 20, 2017