Status:
WITHDRAWN
Comparison of Ventricular Tachycardia Ablation Strategies in Patients With Ischemic Cardiomyopathy
Lead Sponsor:
Montefiore Medical Center
Conditions:
Ventricular Tachycardia
Eligibility:
All Genders
18-99 years
Phase:
EARLY_PHASE1
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) ...
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 23 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04512911
Start Date
January 1 2023
End Date
January 23 2023
Last Update
October 6 2023
Active Locations (1)
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1
Montefiore Medical Center, Cardiology
The Bronx, New York, United States, 10467