Pasquale Santangeli
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.
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 a similar safety profile compared to a contemporary, widely adopted RFA technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SE). ASCEND is a single center, controlled (two-arm), 1:1 parallel-randomized, open-label pilot study of 40 consecutively enrolled patients with ischemic cardiomyopathy and drug refractory or drug intolerant VT in whom a catheter ablation procedure is indica…
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 in…
RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
PFA ablation of VT substrate using FARAPOINT catheter
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