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NCT00750711 Clinical Trial

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

Radiofrequency Ablation Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00750711
Other study ID # Protocole 08-006
Secondary ID
Status Recruiting
Phase N/A
First received September 9, 2008
Last updated September 15, 2008
Start date March 2008

Study information
Verified date September 2008
Source University Hospital, Geneva
Contact Dipen DS Shah, professor
Phone 0041223727197
Email dipen.shah@hcuge.ch
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 200
Est. completion date
Est. primary completion date January 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Procedure:
• Radiofrequency ablation for atrial flutter by catheters

Locations
Country Name City State
Switzerland University Hospital of Geneva Geneva
Switzerland University Hospital of Geneva Geneva

Sponsors (1)
Lead Sponsor Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome
Type Measure Description Time frame Safety issue
Primary Procedural success rate, procedure duration, number of RF applications, delivered power, impedance, complication rate, recurrence at six months 6 months Yes
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