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
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, see Learn About Clinical Studies.

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 July 31, 2014