Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

Early Phase 1

Withdrawn

• Conditions: Ventricular Tachycardia
• Interventions: Procedure: Endocardial ablation; Procedure: Endocardial- Epicardial ablation; Drug: Antiarrhythmic medications

• Registration Number: NCT04512911
• Lead Sponsor: Montefiore Medical Center

Brief 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.

Study Timeline

• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-14
• Study Start: 2023-01
• Primary Completion: 2023-01-23
• Study Completion: 2023-01-23
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-04
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Provision of signed and dated informed consent form
• Stated willingness to comply with all study procedures and availability for the duration of the study
• Male or female, aged 18 or greater
• Patient with ≥ 1 episode of VT (i.e., Sustained VT more than 30 seconds or VT with any ICD therapy)
• Patients with ischemic cardiomyopathy, EF less than 50%, documented history of CAD

Exclusion Criteria

• Patients with ventricular fibrillation.

• Reversible causes of VT.

• Patients with contraindications to systemic anticoagulation with heparin or coumadin, direct thrombin inhibitor or factor Xa inhibitors.

• Patients with prior procedure involving opening the pericardium or entering the pericardial space (e.g., CABG, heart transplantation, valve surgery) were adhesions are suspected

• Any prior ablation for the ventricles or any prior epicardial ablation

• Documented history of myocardial infarction within 1 month prior to the planned study intervention

• Documented symptomatic carotid disease defined as > 70% stenosis or > 50% stenosis with symptoms

• Any history of thoracic radiation with the exception of localized radiation treatment for breast cancer

• Active pericarditis

• Active endocarditis\Any documented history or autoimmune disease associated with pericarditis

• Thrombocytopenia (platelet count < 100 x 109/L)

• Body Mass Index (BMI > 45)

• Patients who are pregnant.

  1. Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients who didn't fail AAD	Endocardial ablation	This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
Patients who didn't fail AAD	Endocardial- Epicardial ablation	This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
Patients who didn't fail AAD	Antiarrhythmic medications	This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
Patients who failed AAD	Endocardial ablation	This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
Patients who failed AAD	Endocardial- Epicardial ablation	This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation

Primary Outcome Measures

Name	Time	Method
Freedom from documented VT episodes	12 months	Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.
Freedom from documented VT episodes after second intervention	12 months after second intervention	Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.

Secondary Outcome Measures

Name	Time	Method
Number of repeat procedures	12, 24 months	Number of repeat ablations
Cost-effectiveness analysis	12 months	The CEA will examine the cost of health care resources and health outcomes from the ablation procedure to 1-year postoperatively. The costs will include all health care utilization during this time. Health care utilization, and associated costs, related to the patients' condition, the procedure and adverse events will be the basis of a sensitivity analysis.
Long-term follow-up to evaluate freedom of documented VT episodes	24 and 60 months	Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (\>30 seconds)
Incidence of peri-procedural and 12-month post procedural complications,	12 months	These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.
Procedure duration and fluoroscopy time	Up to 4 hours (During ablation procedure)	Procedure duration and fluoroscopy time

Trial Locations

Locations (1)

Montefiore Medical Center, Cardiology; 🇺🇸 Bronx, New York, United States