Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
NCT ID: NCT04512911
Last Updated: 2023-10-06
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
WITHDRAWN
Clinical Phase
EARLY_PHASE1
Study Classification
INTERVENTIONAL
Study Start Date
2023-01-31
Study Completion Date
2023-01-23
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Ventricular Tachycardia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
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.
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Outcome Assessors
Due to the nature of the ablation procedures and medications treatment assignment, physicians and patients cannot be blinded to the randomization.
Study Groups
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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
Group Type
ACTIVE_COMPARATOR
Endocardial ablation
Intervention Type
PROCEDURE
Endocardial ablation of VT
Endocardial- Epicardial ablation
Intervention Type
PROCEDURE
Epicardial ablation of VT in addition to endocardial ablation
Antiarrhythmic medications
Intervention Type
DRUG
Addition of anti arrhythmic medication or dose increase
Patients who failed AAD
This group of patients will be randomized to 2 subgroups: 1) Endocardial ablation; 2) Endocardial - Epicardial ablation
Group Type
ACTIVE_COMPARATOR
Endocardial ablation
Intervention Type
PROCEDURE
Endocardial ablation of VT
Endocardial- Epicardial ablation
Intervention Type
PROCEDURE
Epicardial ablation of VT in addition to endocardial ablation
Interventions
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Endocardial ablation
Endocardial ablation of VT
Intervention Type
PROCEDURE
Endocardial- Epicardial ablation
Epicardial ablation of VT in addition to endocardial ablation
Intervention Type
PROCEDURE
Antiarrhythmic medications
Addition of anti arrhythmic medication or dose increase
Intervention Type
DRUG
Eligibility Criteria
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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
* 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
* 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
Minimum Eligible Age
18 Years
Maximum Eligible Age
99 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Montefiore Medical Center
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Jorge Romero, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center/Albert Einstein College of Medicine
Luigi Di Biase, MD
Role: PRINCIPAL_INVESTIGATOR
Montefiore Medical Center/Albert Einstein College of Medicine
Locations
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Montefiore Medical Center, Cardiology
The Bronx, New York, United States
Site Status
Countries
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United States
References
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BACKGROUND
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Meng L, Tseng CH, Shivkumar K, Ajijola O. Efficacy of Stellate Ganglion Blockade in Managing Electrical Storm: A Systematic Review. JACC Clin Electrophysiol. 2017 Sep;3(9):942-949. doi: 10.1016/j.jacep.2017.06.006.
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Other Identifiers
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2019-10639
Identifier Type: -
Identifier Source: org_study_id
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PHASE4
Ventricular Tachycardia (VT) Ablation or Escalated Drug Therapy
NCT00905853
COMPLETED
PHASE4
Radiofrequency Ablation for Polymorphic Ventricular Tachycardia With Heart Failure (RFCA for PMVT-HF)
NCT07130175
COMPLETED
NA
Electroporation vs. Radiofrequency Ablation Guided by 3D Imaging in Repeat Procedures for Atrial Fibrillation
NCT07141745
RECRUITING
NA
Saline-Enhanced Radiofrequency (SERF) Catheter Ablation for the Treatment of Ventricular Tachycardia
NCT02994446
COMPLETED
NA
Cryoballoon Ablation of Pulmonary Veins After Failed RF Ablation in Patients With Paroxysmal AF
NCT01611701
COMPLETED
PHASE3
Ablation of Clinical Ventricular Tachycardia Versus Addition of Substrate Ablation on the Long Term Success Rate of VT Ablation
NCT01045668
COMPLETED
PHASE3
Comparison of RF and crYoballoon ablatiOn Therapy of AF（CRYO-AF）
NCT03044951
UNKNOWN
NA
Catheter Ablation Versus Radio-Ablation for Ventricular Tachycardia: a Randomized Controlled Trial
NCT05047198
RECRUITING
PHASE3
Ablation-Index Guided Scar-Mediated Ventricular Tachycardia Ablation in Patients With Ischemic Cardiomyopathy
NCT06138873
RECRUITING
NA
Fibrillatory Factor in Ventricular Tachycardia
NCT01974908
UNKNOWN
NA
Medtronic Terminate AF Study
NCT03546374
RECRUITING
NA
Cryoballoon vs. Rhythmia Guided Ablation for Recurrent AFib
NCT03811795
UNKNOWN
NA
Complex Arrhythmia Registry
NCT07024927
NOT_YET_RECRUITING
Zero-fluoroscopic Ablation Versus Conventional Fluoroscopic Ablation for the Treatment of Ventricular Arrhythmias
NCT03041519
UNKNOWN
NA
Cardiac Surgical Treatment by Radiofrequency Ablation on Valvular Patients: Efficacy at 3 Months
NCT00259623
COMPLETED
NA
Efficacy of Different Ablation Strategies for Controlling Atrial Fibrillation
NCT00379301
COMPLETED
NA
Ablation vs Amiodarone for Treatment of AFib in Patients With CHF and an ICD
NCT00729911
COMPLETED
PHASE4
Af Ablation In Brady-Tachy Syndrome
NCT00740272
TERMINATED
NA