Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

Ventricular Tachycardia Clinical Trial

— EPI-VT  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04512911
• Other study ID #: 2019-10639
• Status: Withdrawn
• Phase: Early Phase 1
• Start date: January 2023
• Est. completion date: January 23, 2023

Study information

• Verified date: October 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 23, 2023
• Est. primary completion date: January 23, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiomyopathies
• Tachycardia
• Tachycardia, Ventricular
• Ventricular Tachycardia

Intervention

Procedure:
• Endocardial ablation
Endocardial ablation of VT
• Endocardial- Epicardial ablation
Epicardial ablation of VT in addition to endocardial ablation

Drug:
• Antiarrhythmic medications
Addition of anti arrhythmic medication or dose increase

Locations

Country	Name	City	State
United States	Montefiore Medical Center, Cardiology	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (39)

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* Note: There are 39 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Freedom from documented VT episodes	Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.	12 months
Primary	Freedom from documented VT episodes 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.	12 months after second intervention
Secondary	Incidence of peri-procedural and 12-month post procedural complications,	These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.	12 months
Secondary	Procedure duration and fluoroscopy time	Procedure duration and fluoroscopy time	Up to 4 hours (During ablation procedure)
Secondary	Number of repeat procedures	Number of repeat ablations	12, 24 months
Secondary	Cost-effectiveness analysis	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.	12 months
Secondary	Long-term follow-up to evaluate freedom of documented VT episodes	Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (>30 seconds)	24 and 60 months