IRB Study Number 25-401
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
You would be asked to participate in this study if you have a condition where your heart beats rapidly or irregularly. This type of heart condition is called arrhythmia. The name of the arrhythmia is ventricular tachycardia (VT). Your doctor would advised you that you should have a procedure to try and restore normal heart rhythm. This procedure is called an ablation. Radiofrequency ablation (RFA) procedures use electrical energy to form scar tissue to slow conduction of the abnormal rhythm. Pulsed field ablation (PFA) is an investigational (experimental) treatment that uses electric pulses to create pores in cell membranes, which leads to cell death. It targets cardiac muscle cells, or myocytes, while avoiding nerves and blood vessels. It is not approved by the Food and Drug Administration (FDA) for VT.
The purpose of this study is to compare the use of RFA and PFA to destroy the abnormal tissues in the heart and eliminate your irregular heart rhythm. Further the study will be used to show that PFA is as safe and more efficient than other treatment options.
If you agree to participate in the study you will be randomized (like a flip of a coin) to either undergo your procedure with standard of care Radiofrequency ablation (RFA) or investigational Pulsed field ablation (PFA).
Inclusion Criteria
- Age ≥18 years
- Ischemic heart disease with prior myocardial infarction
- Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment
- Documented sustained monomorphic VT with any of the following characteristics:
- ≥2 documented episodes in patients with implantable cardioverter defibrillators (ICD)
- ≥1 documented episode(s) in patients without ICD
- Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions
Exclusion Criteria
Idiopathic VT
Mobile LV thrombus
Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment)
New York Heart Association class IV heart failure
Thrombocytopenia or coagulopathy
Pregnancy or lactation
Cardiac surgery within the past 2 months
Active infection
Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
Any concomitant congenital heart disease
Prior catheter or surgical ablation of VT within the past 2 months.
Pre-existing LVAD or other hemodynamic assist device
Present mechanical heart valve
Allergy to radiographic contrast dye
