NCT04512911

Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a prospective multicenter randomized open-label study aiming to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in achievement of long-term ventricular tachycardia (VT) treatment success.

Detailed description

Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy (EPI VT) is a prospective multicenter randomized controlled study that is planned as a pilot study to include 100 patients. The aim of our study is to assess whether endocardial or endocardial-epicardial ablation is superior to the standard approach (i.e., Antiarrhythmic drugs) in the achievement of long-term ventricular tachycardia (VT) treatment success. Patients will be stratified into two groups depending on the history of taking antiarrhythmic medications (AAD) and each group will be further randomized 1:1 for endocardial and epicardial ablation vs endocardial only ablation in group who failed AAD. And in the group who didn't fail AADs patients will be randomized 1:1:1 into 3 groups: endocardial and epicardial ablation, endocardial only ablation or antiarrhythmic medications. Follow up planned at 3, 6 and 12 months, if VT recurrence is noted, repeated procedure (according to initially allocated group) or adjustment of medications (if AAD group) will be performed. Follow up at 3, 6 and 12 months is also planned after a repeat procedure/ medications adjustment. Primary endpoints include freedom from documented VT episodes (\> 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication and freedom from documented VT episodes (\>30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

Conditions

• Ventricular Tachycardia

Interventions

Type	Name	Description
PROCEDURE	Endocardial ablation	Endocardial ablation of VT
PROCEDURE	Endocardial- Epicardial ablation	Epicardial ablation of VT in addition to endocardial ablation
DRUG	Antiarrhythmic medications	Addition of anti arrhythmic medication or dose increase

Timeline

• Start date: 2023-01-01
• Primary completion: 2023-01-23
• Completion: 2023-01-23
• First posted: 2020-08-14
• Last updated: 2023-10-06

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study