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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2008 by University Hospital, Geneva.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT00750711
First received: September 9, 2008
Last updated: September 15, 2008
Last verified: September 2008
  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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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

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

ClinicalTrials.gov processed this record on April 15, 2014