NCT06891456

Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Pasquale Santangeli · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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.

Conditions

• Ventricular Tachycardia
• Ischemic Heart Disease
• Sustained VT

Interventions

Type	Name	Description
DEVICE	RFA Ablation	RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
DEVICE	PFA Ablation	PFA ablation of VT substrate using FARAPOINT catheter

Timeline

• Start date: 2025-06-16
• Primary completion: 2028-12-31
• Completion: 2028-12-31
• First posted: 2025-03-24
• Last updated: 2025-08-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study