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.
Brief Title
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
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.
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.
Categories
Completion Date
Completion Date Type
Estimated
Conditions
Ventricular Tachycardia
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.
1. Pregnancy will be assessed by urine pregnancy testing prior to the ablation procedure
* 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
Inclusion 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
* 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
Gender
All
Gender Based
false
Keywords
Ventricular tachycardia
Catheter ablation
Epicardial ablation
arrhythmia recurrence
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
99 Years
Minimum Age
18 Years
NCT Id
NCT04512911
Org Class
Other
Org Full Name
Montefiore Medical Center
Org Study Id
2019-10639
Overall Status
Withdrawn
Phases
Early Phase 1
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Primary Outcomes
Outcome Description
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the first ablation procedure or on antiarrhythmic medication.
Outcome Measure
Freedom from documented VT episodes
Outcome Time Frame
12 months
Outcome Description
Freedom from documented VT episodes (greater than 30 seconds) at 12 months after the second ablation procedure or on two antiarrhythmics combined.
Outcome Measure
Freedom from documented VT episodes after second intervention
Outcome Time Frame
12 months after second intervention
Secondary Outcomes
Outcome Description
These complications include but not limited to ischemic stroke, cardiac perforation, rehospitalization, and death.
Outcome Time Frame
12 months
Outcome Measure
Incidence of peri-procedural and 12-month post procedural complications,
Outcome Description
Procedure duration and fluoroscopy time
Outcome Time Frame
Up to 4 hours (During ablation procedure)
Outcome Measure
Procedure duration and fluoroscopy time
Outcome Description
Number of repeat ablations
Outcome Time Frame
12, 24 months
Outcome Measure
Number of repeat procedures
Outcome 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.
Outcome Time Frame
12 months
Outcome Measure
Cost-effectiveness analysis
Outcome Description
Long-term follow-up at 24 and 60 months to evaluate freedom of documented VT episodes (\>30 seconds)
Outcome Time Frame
24 and 60 months
Outcome Measure
Long-term follow-up to evaluate freedom of documented VT episodes
Start Date
Start Date Type
Estimated
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
99
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Luigi Dibiase
Investigator Email
ldibiase@montefiore.org
Investigator Phone
347-271-1637