Clinical trial NCT04512911: Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
Official title: Endocardial-Epicardial Radiofrequency Ablation of Ventricular Tachycardia in Patients With Ischemic Cardiomyopathy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Ventricular Tachycardia
Keywords: Ventricular tachycardia
Catheter ablation
Epicardial ablation
arrhythmia recurrence
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2020-08-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Freedom from documented VT episodes
timeFrame: 12 months
measure: Freedom from documented VT episodes after second intervention
timeFrame: 12 months after second intervention
Secondary outcomes:
measure: Incidence of peri-procedural and 12-month post procedural complications,
timeFrame: 12 months
measure: Procedure duration and fluoroscopy time
timeFrame: Up to 4 hours (During ablation procedure)
measure: Number of repeat procedures
timeFrame: 12, 24 months
measure: Cost-effectiveness analysis
timeFrame: 12 months
measure: Long-term follow-up to evaluate freedom of documented VT episodes
timeFrame: 24 and 60 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Cardiology
state: New York
Study officials:
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Jorge Romero, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Montefiore Medical Center/Albert Einstein College of Medicine
name: Luigi Di Biase, MD
role: PRINCIPAL_INVESTIGATOR
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