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

Primary Purpose

Ventricular Tachycardia

Status
Withdrawn
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Endocardial ablation
Endocardial- Epicardial ablation
Antiarrhythmic medications
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ventricular Tachycardia focused on measuring Ventricular tachycardia, Catheter ablation, Epicardial ablation, arrhythmia recurrence

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Montefiore Medical Center, Cardiology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Patients who didn't fail AAD

Patients who failed AAD

Arm Description

This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications

This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Incidence of peri-procedural and 12-month post procedural complications,
These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.
Procedure duration and fluoroscopy time
Procedure duration and fluoroscopy time
Number of repeat procedures
Number of repeat ablations
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.
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)

Full Information

First Posted
August 11, 2020
Last Updated
October 4, 2023
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04512911
Brief Title
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
Acronym
EPI-VT
Official Title
Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Withdrawn
Why Stopped
IRB approval expired 1/23/2023 and eclipsed the 6 month institutional window where study can be reinitiated via progress report. No enrollment has taken place.
Study Start Date
January 2023 (Anticipated)
Primary Completion Date
January 23, 2023 (Anticipated)
Study Completion Date
January 23, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventricular Tachycardia
Keywords
Ventricular tachycardia, Catheter ablation, Epicardial ablation, arrhythmia recurrence

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Model Description
A total of 100 patients will be randomized in 1:1 fashion to investigation arms Endocardial - Epicardial (20 patients) or Endocardial ablation (20 patients) if patients have previously failed AAD and in 1:1:1 fashion randomization to Endocardial - Epicardial ablation (20 patients), Endocardial ablation (20 patients) and AAD (20 patients) if patients have not failed AAD previously. If during follow up VT recurrence occurs, treatment method that patient was assigned to will be considered failed and patients will undergo redo ablation (same as previously assigned to) or if AAD failed patient will be added a second AAD or changed to another AAD. If during follow up after second procedure or adjustment of AAD patient experiences VT recurrence the treatment method will be considered failed.
Masking
Outcomes Assessor
Masking Description
Due to the nature of the ablation procedures and medications treatment assignment, physicians and patients cannot be blinded to the randomization.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients who didn't fail AAD
Arm Type
Active Comparator
Arm Description
This group of patients will be randomized to 3 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation; 3) Antiarrhythmic medications
Arm Title
Patients who failed AAD
Arm Type
Active Comparator
Arm Description
This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
Intervention Type
Procedure
Intervention Name(s)
Endocardial ablation
Intervention Description
Endocardial ablation of VT
Intervention Type
Procedure
Intervention Name(s)
Endocardial- Epicardial ablation
Intervention Description
Epicardial ablation of VT in addition to endocardial ablation
Intervention Type
Drug
Intervention Name(s)
Antiarrhythmic medications
Intervention Description
Addition of anti arrhythmic medication or dose increase
Primary Outcome Measure Information:
Title
Freedom from documented VT episodes
Description
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.
Time Frame
12 months
Title
Freedom from documented VT episodes after second intervention
Description
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.
Time Frame
12 months after second intervention
Secondary Outcome Measure Information:
Title
Incidence of peri-procedural and 12-month post procedural complications,
Description
These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.
Time Frame
12 months
Title
Procedure duration and fluoroscopy time
Description
Procedure duration and fluoroscopy time
Time Frame
Up to 4 hours (During ablation procedure)
Title
Number of repeat procedures
Description
Number of repeat ablations
Time Frame
12, 24 months
Title
Cost-effectiveness analysis
Description
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.
Time Frame
12 months
Title
Long-term follow-up to evaluate freedom of documented VT episodes
Description
Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (>30 seconds)
Time Frame
24 and 60 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Romero, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luigi Di Biase, MD
Organizational Affiliation
Montefiore Medical Center/Albert Einstein College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center, Cardiology
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
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Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

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