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Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia — VT-CoA  

Ventricular Tachycardia Clinical Trial

Official title:
NaviStar ThermoCool Catheter for Endocardial RF Ablation in Patients With Ventricular Tachycardia

Clinical Trial Summary

The primary objective is to provide additional corroborative safety and efficacy data for the Navistar ThermoCool catheter for the treatment of subjects with ischemic Ventricular Tachycardia.

Clinical Trial Description

This study is a prospective, non-randomized, single-arm, multi-center condition of approval evaluation. The device is currently FDA approved for commercial distribution. Subjects with ischemic ventricular tachycardia will be considered for the condition of approval study. This study will be conducted at up to 30 centers in a minimum of 249 evaluable subjects. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00412607
Study type Interventional
Source Biosense Webster, Inc.
Contact
Status Completed
Phase Phase 4
Start date January 2007
Completion date June 2012
View Details
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