Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy (EPI-VT)

October 4, 2023 updated by: Montefiore Medical Center

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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 Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10467
        • Montefiore Medical Center, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Patients who didn't fail AAD
This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
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
Active Comparator: Patients who failed AAD
This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
Procedure: Endocardial ablation
Endocardial ablation of VT
Procedure: Endocardial- Epicardial ablation
Epicardial ablation of VT in addition to endocardial ablation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freedom from documented VT episodes
Time Frame: 12 months
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.
12 months
Freedom from documented VT episodes after second intervention
Time Frame: 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.
12 months after second intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness analysis
Time Frame: 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.
12 months
Incidence of peri-procedural and 12-month post procedural complications,
Time Frame: 12 months
These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.
12 months
Procedure duration and fluoroscopy time
Time Frame: Up to 4 hours (During ablation procedure)
Procedure duration and fluoroscopy time
Up to 4 hours (During ablation procedure)
Number of repeat procedures
Time Frame: 12, 24 months
Number of repeat ablations
12, 24 months
Long-term follow-up to evaluate freedom of documented VT episodes
Time Frame: 24 and 60 months
Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (>30 seconds)
24 and 60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montefiore Medical Center

Investigators

  • Principal Investigator: Jorge Romero, MD, Montefiore Medical Center/Albert Einstein College of Medicine
  • Principal Investigator: Luigi Di Biase, MD, Montefiore Medical Center/Albert Einstein College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2023

Primary Completion (Estimated)

January 23, 2023

Study Completion (Estimated)

January 23, 2023

Study Registration Dates

First Submitted

August 11, 2020

First Submitted That Met QC Criteria

August 11, 2020

First Posted (Actual)

August 14, 2020

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

October 4, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-10639

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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