Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
NCT06891456 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2025-08-19
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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