Pulse Field Ablation for Post-Infarction Ventricular Tachycardia: the ASCEND Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Procedural Efficiency
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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/1.73m
- •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
研究组 & 干预措施
RFA Ablation
VT ablation with ThermoCool ST, FlexAbility SE, ThermoCool ST SF or TactiFlex SE catheters
干预措施: RFA Ablation (Device)
PFA Ablation
VT ablation with FARAPOINT catheter
干预措施: PFA Ablation (Device)
结局指标
主要结局
Procedural Efficiency
时间窗: Periprocedural
Total ablation time (in seconds) needed to achieve complete elimination of late abnormal ventricular activities (LAVAs) in myocardial scar.
Procedural Safety
时间窗: Within 7 days post procedure
Count of individuals who experience any of the following: * Cardiac perforation * Pericardial effusion with hemodynamic compromise or needing intervention * New complete heart block * Coronary spasm * Acute MI * New acute severe mitral regurgitation or aortic regurgitation * Deep venous thrombosis * Vascular injury requiring surgical or percutaneous intervention * Pulmonary embolism * Stroke * Acute kidney injury * Death
次要结局
- Secondary Safety(180 days post procedure)
研究者
Pasquale Santangeli
Sponsor-Investigator
The Cleveland Clinic