Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

NCT06891456 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-08-19

No results posted yet for this study

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.

Conditions

  • Ventricular Tachycardia
  • Ischemic Heart Disease
  • Sustained VT

Interventions

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

Sponsors & Collaborators

  • Boston Scientific Corporation

    collaborator INDUSTRY
  • Pasquale Santangeli

    lead OTHER

Principal Investigators

  • Pasquale Santangeli, MD, PhD · The Cleveland Clinic

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-06-16
Primary Completion
2028-12-31
Completion
2028-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06891456 on ClinicalTrials.gov