Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

The ASCEND trial is a pilot study that will test the hypothesis that the novel FARAPOINT catheter and the FARAPULSE PFA platform can accomplish ischemic substrate VT ablation more efficiently and with a similar safety profile compared to a contemporary, widely adopted RFA technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE).

ASCEND is a single center, controlled (two-arm), 1:1 parallel-randomized, open-label pilot study of 40 consecutively enrolled patients with ischemic cardiomyopathy and drug refractory or drug intolerant VT in whom a catheter ablation procedure is indicated. The study intervention consists of the use of a novel FARAPOINT PFA catheter during the entire VT ablation procedure. Patients randomized to the control arm of the study will undergo VT ablation using a contemporary standard-of-care technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SEcatheters).

This pilot study is designed to test for superiority with respect to the primary efficacy metric and to ensure comparable safety profiles of both ablation methods.

Inclusion criteria

must meet all of the following:

• 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:

• ≥2documented 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
• Provision of signed and dated informed consent form.
• Stated willingness to comply with all study procedures and availability for the duration of the study.

Exclusion criteria

any of the following:

• Unable to provide informed consent.
• Idiopathic VT.
• Mobile LV thrombus.
• Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
• Comorbidity likely to limit survival to <12 months
• New York Heart Association class IV heart failure.
• Estimated glomerular filtration rate <30 ml/min/1.73m2.
• Thrombocytopenia or coagulopathy.
• Contraindication to heparin.
• Pregnancy or lactation.
• Cardiac surgery within the past 2 months.
• Active infection.
• Clinical, laboratory or imaging evidence of active ischemia.
• 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.
• Anticipated need for epicardial mapping and ablation.
• For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
• Pre-existing LVAD or other hemodynamic assist device
• Present mechanical heart valve
• cardiogenic shock unless it is due to incessant VT