Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy

Withdrawn before enrolling · Early Phase 1

Conditions studied: Ventricular Tachycardia

In brief

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.

Key facts

Study ID

NCT04512911

Run by

Montefiore Medical Center

People needed

0

Starts

2023-01-01

Expected to finish

2023-01-23

Last updated by the study team

2023-10-06

Who can join

Age: 18 and older, up to 99. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Montefiore Medical Center, Cardiology — The Bronx, New York, United States

Full record on ClinicalTrials.gov

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