Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

Launched by THE CLEVELAND CLINIC · Mar 17, 2025

Keywords

ClinConnect Summary

The ASCEND trial is a research study that aims to compare two different methods of treating a heart condition called ventricular tachycardia (VT), which can occur in patients who have had a heart attack. The trial is specifically looking at a new technique called pulsed field ablation (PFA) using a special catheter called FARAPOINT, and comparing it to the standard method known as radiofrequency ablation (RFA). The goal is to see if PFA is more effective while still being safe for patients.

To participate in this study, you need to be at least 18 years old and have a history of ischemic heart disease, which means your heart has been damaged due to lack of blood flow, typically from a heart attack. You should also have a specific type of VT, either documented through episodes or not responding to medications. However, there are certain conditions that would exclude you from participating, such as severe heart failure or recent heart surgery. If you're eligible and choose to join, you would undergo treatment and be monitored throughout the study to assess how well the new technique works compared to the standard approach.

Gender

ALL

Eligibility criteria

• Inclusion Criteria: must meet all of the following:
• • 1. Age ≥18 years.
• • 2. Ischemic heart disease with prior myocardial infarction.
• • 3. Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment.
• 4. Documented sustained monomorphic VT with any of the following characteristics:
• • 1. ≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)
• • 2. ≥1 documented episode(s) in patients without ICD
• • 3. Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions
• • 5. Provision of signed and dated informed consent form.
• • 6. Stated willingness to comply with all study procedures and availability for the duration of the study.
• Exclusion Criteria: any of the following:
• • 1. Unable to provide informed consent.
• • 2. Idiopathic VT.
• • 3. Mobile LV thrombus.
• • 4. Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
• • 5. Comorbidity likely to limit survival to \<12 months
• • 6. New York Heart Association class IV heart failure.
• • 7. Estimated glomerular filtration rate \<30 ml/min/1.73m2.
• • 8. Thrombocytopenia or coagulopathy.
• • 9. Contraindication to heparin.
• • 10. Pregnancy or lactation.
• • 11. Cardiac surgery within the past 2 months.
• • 12. Active infection.
• • 13. Clinical, laboratory or imaging evidence of active ischemia.
• • 14. Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
• • 15. Any concomitant congenital heart disease.
• • 16. Prior catheter or surgical ablation of VT within the past 2 months.
• • 17. Anticipated need for epicardial mapping and ablation.
• • 18. For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
• • 19. Pre-existing LVAD or other hemodynamic assist device
• • 20. Present mechanical heart valve
• • 21. allergy to radiographic contrast dye
• • 22. cardiogenic shock unless it is due to incessant VT