NCT06891456 · Pasquale Santangeli
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
(ASCEND-VT)
What this study is about
ASCEND is a randomly assigned controlled where both patients and doctors know the treatment given 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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- must meet all of the following:
- 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 criteria
- any of the following:
- 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
Where
- Cleveland, Ohio
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 19, 2025 · Source of record for eligibility and locations