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NCT06891456
Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia
Conditions: Ventricular Tachycardia, Ischemic Heart Disease, Sustained VT
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Pasquale Santangeli
Location: Cleveland Clinic Cleveland Ohio
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.
Eligibility Criteria
Inclusion Criteria: must meet all of the following:
1. Age ≥18 years.
2. Ischemic heart disease with prior myocardial infarction.
3. Left ventricular ejection fraction ≥20% estimated by transthoracic echocardiography (TTE) within 90 days prior to enrollment.
4. Documented sustained monomorphic VT with any of the following characteristics:
1. ≥2documented episodes in patients with implantable cardioverter defibrillators (ICD)
2. ≥1 documented episode(s) in patients without ICD
3. Recurrent VT despite antiarrhythmic medications (ineffective, contraindicated or not tolerated) or ICD interventions
5. Provision of signed and dated informed consent form.
6. Stated willingness to comply with all study procedures and availability for the duration of the study.
Exclusion Criteria: any of the following:
1. Unable to provide informed consent.
2. Idiopathic VT.
3. Mobile LV thrombus.
4. Acute coronary syndrome within the preceding 2 months (if incessant VT ≥1 month before enrollment).
5. Comorbidity likely to limit survival to \
Source: ClinicalTrials.gov (NCT06891456). StuddyBuddy aggregates publicly available trial information.