Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

• Status: Active, not recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Montefiore Medical Center
• Treatments: Anti-Arrhythmia Agents

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