Pulsed Field Ablation for Post-Infarction Ventricular Tachycardia

Официальное название

Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study

Обзор

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.

Подробное описание

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 indicated. The study intervention consists of the use of a novel FARAPOINT PFA catheter during the entire VT ablation procedure. Patients randomized to the control arm of the study will undergo VT ablation using a contemporary standard-of-care technology (ThermoCool ST/FlexAbility SE/ThermoCool ST SF/TactiFlex SEcatheters).

This pilot study is designed to test for superiority with respect to the primary efficacy metric and to ensure comparable safety profiles of both ablation methods.

Вмешательства

• Устройство RFA Ablation
  RFA ablation of VT substrate using FlexAbility or ThermoCool ST catheter
• Устройство PFA Ablation
  PFA ablation of VT substrate using FARAPOINT catheter

Первичные конечные точки

• Procedural Efficiency [Срок оценки: Periprocedural]
• Procedural Safety [Срок оценки: Within 7 days post procedure]

Вторичные конечные точки (1)

• Secondary Safety [Срок оценки: 180 days post procedure]

Критерии участия

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Cleveland Clinic — Cleveland

Идентификаторы

NCT: NCT06891456 · G250026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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