Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

Not Applicable

Completed

• Conditions: Atrial Flutter
• Interventions: Procedure: cavotricuspid isthmus ablation; Device: remote magnetic catheter navigation

• Registration Number: NCT00560872
• Lead Sponsor: University Hospital Goettingen

Brief Summary

The purpose of this study is to evaluate the influence of remote magnetic catheter navigation on the safety and efficacy of mapping and radiofrequency ablation of the cavotricuspid isthmus in patients with typical atrial flutter.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-08
• Study First Submitted: 2007-11-19
• Study First Submitted QC: 2007-11-19
• Study First Posted: 2007-11-20
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Status Verified: 2009-12
• Last Update Submitted: 2009-12-22
• Last Update Posted: 2009-12-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• ECG documentation of at least 1 episode of typical atrial flutter

Exclusion Criteria

• Prior right atrial ablation
• Ferromagnetic implants that may interfere with the magnetic navigation system
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	cavotricuspid isthmus ablation	conventional ablation with manual catheter navigation
2	remote magnetic catheter navigation	ablation with remote magnetic catheter navigation

Primary Outcome Measures

Name	Time	Method
ablation duration and fluoroscopy time	3 months

Secondary Outcome Measures

Name	Time	Method
total procedure duration, success, ablation characteristics, flutter recurrence, complications	6 months

Trial Locations

Locations (1)

Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet; 🇩🇪 Goettingen, Germany