NCT06891456Recruiting
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study
Source: ClinicalTrials.gov · Last updated 3 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 12 Mar 2025
- Start date
- 16 Jun 2025
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Pasquale Santangeli
- Diseases
- Coronary artery disease
- NCT number
- NCT06891456
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 16 Jun 2025 to the primary completion date, 31 Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
- Any concomitant congenital heart disease.
- Prior catheter or surgical ablation of VT within the past 2 months.
- For individuals with no pre-existing ICD: Ineligibility for an ICD implant.
Other illness
- New York Heart Association class IV heart failure.
- Cardiac surgery within the past 2 months.
- Active infection.
- Severe left heart valvular heart disease (aortic/mitral stenosis or regurgitation).
- Present mechanical heart valve
Lab values
- Clinical, laboratory or imaging evidence of active ischemia.
Other
- Unable to provide informed consent.
- Idiopathic VT.
- Mobile LV thrombus.
- Comorbidity likely to limit survival to \<12 months
- Estimated glomerular filtration rate \<30 ml/min/1.73m2.
- Thrombocytopenia or coagulopathy.
- Contraindication to heparin.
- Pregnancy or lactation.
- Anticipated need for epicardial mapping and ablation.
- Pre-existing LVAD or other hemodynamic assist device
- cardiogenic shock unless it is due to incessant VT
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cleveland Clinic Coordinator of this site? Confirm its status | Cleveland | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.