NCT00905853

Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy

Ventricular Tachycardia Ablation or Escalated aNtiarrhythmic Drugs in ISchemic Heart Disease

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 260 (actual)
• Sponsor: John Sapp · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will compare aggressive antiarrhythmic therapy to catheter ablation for ventricular tachycardia in patients who have suffered prior myocardial infarction. The purpose of this study is to evaluate the optimal management of patients presenting with recurrent VT and receiving ICD therapy in spite of first-line antiarrhythmic drug therapy. The hypothesis is catheter ablation is superior to aggressive antiarrhythmic drug therapy for recurrent VT.

Detailed description

This is a multicentre, parallel group, two arm, unblinded, randomized clinical trial to compare two management strategies for patients with ischemic heart disease and recurrent ICD therapy despite at least one antiarrhythmic drug. The primary endpoint will be a composite of appropriate ICD shocks or death.

Conditions

• Recurrent Ventricular Tachycardia

Interventions

Type	Name	Description
PROCEDURE	Catheter Ablation	Intracardiac electrode catheters are placed via central vasculature to identify myocardial scar, and surviving conduction channels within the scar which form the substrate for ventricular tachycardia. Radiofrequency energy is applied to these sites, interrupting the VT circuits.
DRUG	Escalated Antiarrhythmic Therapy	Patients who have 'failed' antiarrhythmic therapy (except amiodarone) will be prescribed: Amiodarone 400 mg twice daily for 2 weeks, followed by 400 mg/day for 4 weeks, followed by 200 mg/day thereafter. Patients who 'failed' amiodarone (less than 300mg/day) will be prescribed: Amiodarone 400 mg three times a day for 2 weeks, followed by 400 mg/day for 1 week and 300 mg/day thereafter. Patients who 'failed' amiodarone (greater or equal to 300mg/day) will be prescribed: Amiodarone at the current dose with the addition of mexiletine 400 to 800 mg/day

Timeline

• Start date: 2009-05-01
• Primary completion: 2015-12-01
• Completion: 2015-12-01
• First posted: 2009-05-21
• Last updated: 2016-07-11

Locations

1 site across 1 country: Canada