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NCT00560872 Clinical Trial

Remote Magnetic Navigation For Cavotricuspid Isthmus Ablation

Atrial Flutter Clinical Trial

Official title:
Randomized Controlled Study of Remote Magnetic Catheter Navigation for Cavotricuspid Isthmus Mapping and Ablation in Patients With Typical Atrial Flutter

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00560872
Other study ID # MN-07-022-GOE
Secondary ID Stereotaxis#07-0
Status Completed
Phase N/A
First received November 19, 2007
Last updated December 22, 2009
Start date August 2007
Est. completion date June 2009

Study information
Verified date December 2009
Source University Hospital Goettingen
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date June 2009
Est. primary completion date December 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Device:
• remote magnetic catheter navigation
use of the Stereotaxis system
Procedure:
• cavotricuspid isthmus ablation
conventional (manual) approach

Locations
Country Name City State
Germany Herzzentrum, Abteilung Kardiologie, Georg-August-Universitaet Goettingen

Sponsors (2)
Lead Sponsor Collaborator
University Hospital Goettingen Stereotaxis

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary ablation duration and fluoroscopy time 3 months No
Secondary total procedure duration, success, ablation characteristics, flutter recurrence, complications 6 months No
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