NCT00412607

Catheter Evaluation for Endocardial Ablation in Patients With Ventricular Tachycardia

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 249 (actual)
• Sponsor: Biosense Webster, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
DEVICE	NAVISTAR® THERMOCOOL® Catheter	The primary objective is to provide additional, corroborative safety data for the NAVISTAR THERMOCOOL catheter for the treatment of subjects with sustained, monomorphic VT or incessant VT associated with coronary artery disease

Timeline

• Start date: 2007-01-01
• Primary completion: 2012-06-01
• Completion: 2012-06-01
• First posted: 2006-12-18
• Last updated: 2025-02-04
• Results posted: 2014-10-16