Status:
RECRUITING
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Lead Sponsor:
Pasquale Santangeli
Collaborating Sponsors:
Boston Scientific Corporation
Conditions:
Ventricular Tachycardia
Ischemic Heart Disease
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 radiofrequenc...
Detailed Description
The ASCEND trial is a pilot study that will test the hypothesis that the novel FARAPOINT catheter and the FARAPULSE PFA platform can accomplish ischemic substrate VT ablation more efficiently and with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 16 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06891456
Start Date
June 16 2025
End Date
December 31 2028
Last Update
August 19 2025
Active Locations (1)
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1
Cleveland Clinic
Cleveland, Ohio, United States, 44195