Pulsed field ablation versus radiofrequency for ventricular tachycardia after a heart attack

Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study

This trial will test whether pulsed field ablation (FARAPOINT) can treat ventricular tachycardia after a heart attack more efficiently and with similar safety compared with standard radiofrequency ablation in people with ischemic cardiomyopathy.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Cleveland Clinic (other)
• Locations: 1 site (Cleveland, Ohio)
• Trial ID: NCT06891456 on ClinicalTrials.gov

What this trial studies

ASCEND is a single-center, randomized, open-label pilot comparing a novel FARAPOINT pulsed field ablation (PFA) catheter with contemporary radiofrequency (RFA) catheters for ischemic substrate ventricular tachycardia (VT) ablation. Forty patients with ischemic cardiomyopathy and drug-refractory or drug-intolerant sustained monomorphic VT will be randomized 1:1 to PFA or RFA and treated at the Cleveland Clinic. The study is designed to test for superiority on a primary efficacy metric while ensuring comparable safety profiles between arms. Procedures use the FARAPOINT/FARAPULSE platform for PFA versus ThermoCool/FlexAbility/TactiFlex family catheters for standard RFA.

Who should consider this trial

Good fit: Adults (≥18) with prior myocardial infarction and ischemic cardiomyopathy who have documented sustained monomorphic VT (drug-refractory, intolerant, or requiring ICD intervention) and an LVEF ≥20% are the intended participants.

Not a fit: People with idiopathic VT, a mobile left ventricular thrombus, recent acute coronary syndrome, very low LVEF below study thresholds, or who cannot undergo catheter ablation are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could deliver faster or more efficient VT ablation with similar safety, potentially reducing procedure time and VT recurrence.

How similar studies have performed: Pulsed field ablation has shown promising safety and effectiveness for atrial fibrillation, but its use for ischemic VT is novel and supported only by early pilot data.

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. cardiogenic shock unless it is due to incessant VT

Where this trial is running

Cleveland, Ohio

• Cleveland Clinic — Cleveland, Ohio, United States (RECRUITING)

Study contacts

• Principal investigator: Pasquale Santangeli, MD, PhD — The Cleveland Clinic
• Study coordinator: Pasquale Santangeli, MD, PhD

Conditions: Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT