Actively Recruiting
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Led by Pasquale Santangeli · Updated on 2025-08-19
40
Participants Needed
1
Research Sites
184 weeks
Total Duration
On this page
Sponsors
P
Pasquale Santangeli
Lead Sponsor
B
Boston Scientific Corporation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Ischemic heart disease with prior myocardial infarction
- Left ventricular ejection fraction 20% or higher estimated by transthoracic echocardiography within 90 days prior to enrollment
- Documented sustained monomorphic ventricular tachycardia with one or more episodes depending on ICD status or recurrent VT despite antiarrhythmic medications or ICD interventions
- Signed and dated informed consent form
- Willingness to comply with all study procedures and availability for study duration
You will not qualify if you...
- Unable to provide informed consent
- Idiopathic ventricular tachycardia
- Mobile left ventricular thrombus
- Acute coronary syndrome within 2 months (or incessant VT within 1 month before enrollment)
- Comorbidities likely to limit survival to less than 12 months
- New York Heart Association class IV heart failure
- Estimated glomerular filtration rate less than 30 ml/min/1.73m2
- Thrombocytopenia or coagulopathy
- Contraindication to heparin
- Pregnancy or lactation
- Cardiac surgery within past 2 months
- Active infection
- Evidence of active ischemia by clinical, laboratory, or imaging
- Severe left heart valvular disease (aortic or mitral stenosis or regurgitation)
- Any congenital heart disease
- Prior catheter or surgical VT ablation within past 2 months
- Anticipated need for epicardial mapping and ablation
- Ineligibility for ICD implant if no pre-existing ICD
- Pre-existing left ventricular assist device or other hemodynamic assist device
- Presence of mechanical heart valve
- Cardiogenic shock unless due to incessant VT
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Cleveland Clinic
Cleveland, Ohio, United States, 44195
Actively Recruiting
Research Team
P
Pasquale Santangeli, MD, PhD
CONTACT
Y
Yuki Kuramochi, BSN, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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