NCT01546207

Stepwise Approach To sUbstrate Modification for Ventricular Tachycardia

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Vivek Reddy · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The goal of this trial is to test the impact of a step-wise approach for catheter ablation of recurrent ventricular tachycardia, (irregular heart rhythms that originate in the bottom chambers of the heart), in patients with a previous heart attack for whom catheter ablation is clinically indicated.

Detailed description

Sudden cardiac death due to VT (ventricular tachycardia) or VF (ventricular fibrillation) occurs at an estimated rate of 300,000 events per year in United States, accounting for 5.6% of annual mortality22. A significant proportion of patients treated with ICDs (implantable defibrillators) will receive shocks due to recurrent VT, resulting in increased mortality8. As a result, catheter-based ablation has emerged as an effective treatment for recurrent VT. However, no study has assessed the impact of a step-wise approach on the outcome of catheter ablation of VT. The investigators propose a prospective, multicenter, non-randomized, single-arm trial to evaluate the impact of a step-wise approach to catheter ablation on ventricular tachycardia recurrence. Given the increasing use of catheter ablation in patients with recurrent ventricular tachycardia, this study will answer a critical question regarding the impact of a step-wise approach on the inducibility of VT at the end of the procedure and clinical recurrences of ventricular arrhythmias at 6 months.

Conditions

• Ventricular Tachycardia
• Catheter Ablation
• Tachycardia, Ventricular

Interventions

Type	Name	Description
PROCEDURE	catheter-based ablation	specific electrophysiological and mapping techniques of activation and entrainment mapping during ongoing VT. Substrate mapping and ablation (substrate modification.) catheter ablation - a medical procedure used to treat some types of arrhythmia

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-08-01
• Completion: 2013-08-01
• First posted: 2012-03-07
• Last updated: 2020-01-13
• Results posted: 2014-04-24

Locations

10 sites across 5 countries: United States, Brazil, Canada, Czechia, Italy