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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
Sponsor:
ClinicalTrials.gov Identifier:
NCT00750711
First Posted: September 10, 2008
Last Update Posted: September 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital, Geneva
  Purpose
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: None (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

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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
  Contacts and Locations
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
  More Information

Responsible Party: Dipen Shah, University Hospital of Geneva
ClinicalTrials.gov Identifier: NCT00750711     History of Changes
Other Study ID Numbers: Protocole 08-006
First Submitted: September 9, 2008
First Posted: September 10, 2008
Last Update Posted: September 16, 2008
Last Verified: September 2008

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