RecruitingNot ApplicableNCT06891456

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

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

Sponsor

Pasquale Santangeli

Enrollment

40 participants

Start Date

Jun 16, 2025

Study Type

INTERVENTIONAL

Conditions

Ventricular Tachycardia Ischemic Heart Disease Sustained VT

Summary

ASCEND is a randomized controlled open-label pilot study evaluating the safety and effectiveness of pulsed field ablation (PFA) with the novel FARAPOINT catheter compared to the standard radiofrequency (RFA) ablation with ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE of ventricular tachycardia (VT) in the patients with ischemic cardiomyopathy and implantable cardioverter-defibrillator (ICD). The study hypothesis is that the PFA ablation is more efficient compared to the RFA technique but retains a comparable safety profile.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria21

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