Pivotal Study to Evaluate Catheter Ablation in Patients With Scar-Related Monomorphic Sustained VT in the Ventricular Ectopy and Reduction in Tachycardia Ablation Studies Program (VERITAS SCAR VT)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
- 主要终点
- Occurrence of causal or probable device or procedure related Major Adverse Events (MAEs) that occur within seven (7) days post-index procedure,
研究概览
简要总结
The VERITAS VT Study is a prospective, multicenter, international, single-arm clinical investigation designed to evaluate the safety and effectiveness of the FieldForce™ Pulsed Field Ablation System for the treatment of sustained monomorphic ventricular tachycardia (VT). Eligible patients undergoing catheter ablation for VT will receive treatment with the investigational pulsed field ablation system according to the study protocol.
The study will assess acute and chronic outcomes including major adverse events, freedom from recurrent ventricular tachycardia, need for antiarrhythmic drug escalation, repeat ablation procedures, and other clinically relevant outcomes through 180 days following the index ablation procedure.
详细描述
Ventricular tachycardia remains a significant source of morbidity and mortality among patients with structural heart disease. Although catheter ablation is an established therapeutic option, long-term recurrence rates remain substantial and procedural challenges continue to exist.
The VERITAS VT Study is a prospective, multicenter, single-arm clinical investigation evaluating the safety and effectiveness of the Field Force Pulsed Field Ablation System in subjects with sustained monomorphic ventricular tachycardia. Eligible participants will undergo mapping and ablation using the Field Force Pulsed Field Ablation System during the index procedure. Subjects will be followed for 180 days after the index procedure to assess safety and effectiveness outcomes.
The primary safety objective is to evaluate the incidence of device- and procedure-related major adverse events. The primary effectiveness objective is to evaluate freedom from recurrence of sustained monomorphic ventricular tachycardia through 180 days following the index ablation procedure
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed patient informed consent form (ICF).
- •Female and male patients aged ≥ 18 and ≤ 85 years.
- •Implantable Cardioverter-Defibrillator (ICD) implanted ≥ 180 days prior to enrollment.
- •Clinically Indicated for ventricular tachycardia (VT) ablation by 2019 guidelines:
- •At least one (1) episode of VT, defined as continuous VT lasting > 30 seconds or requiring termination due to hemodynamic compromise, detected by an implanted ICD ≤ 180 days prior to enrollment and
- •Refractory to, contraindicated or intolerant of at least one (1) Class I or III Antiarrhythmic Drug (AAD)
- •Sustained scar-related monomorphic ventricular tachycardia (MMVT):
- •Objective evidence of ventricular scar confirmed by imaging (magnetic resonance imaging (MRI), computed tomography (CT), positron emission tomography (PET), intracardiac echocardiography/ transesophageal echocardiogram (ICE/TEE) and/or electro anatomical mapping (EAM)) Or
- •Prior myocardial infarction (MI)
- •Left ventricular ejection fraction (LVEF) ≥ 20% confirmed by echocardiography or comparable imaging techniques within 180 days prior to enrollment or during baseline evaluation.
排除标准
- •Subjects will be excluded if ANY of the following apply:
- •VT secondary to reversible causes (e.g. electrolyte abnormalities, drug or alcohol-induced arrhythmia or non-cardiac cause).
- •VT ablation within 14 days prior to enrollment.
- •Greater than three (3) VT ablations within one (1) year prior to enrollment.
- •Ventricular fibrillation (VF), polymorphic VT or Torsades de Pointes (TdP) as primary clinical arrhythmia.
- •Bundle branch reentry (BBR), Idiopathic, Para-Hisian or Fascicular VT.
- •For non-ischemic cardiomyopathy (NICM) if the following apply:
- •Active (within 120 days) inflammatory process (e.g. myocarditis)
- •Sarcoidosis
- •Hypertrophic cardiomyopathy (HCM)
- •Laminopathy (LMNA-related cardiomyopathy)
- •Brugada syndrome (BrS)
- •Amyloidosis
- •Acute myocardial infarction ≤ 90 days prior to enrollment.
- •Recent cardiac intervention ≤ 90 days prior to enrollment including but not limited to Percutaneous Coronary Intervention (PCI) or Coronary Artery Bypass Graft (CABG), lead revision or upgrade, etc.
- •Implanted with a ventricular assist device (VAD).
- •Severe mitral or aortic regurgitation or stenosis evaluated by echo or comparable technique.
- •Presence of an aortic or mitral mechanical valve.
- •New York Heart Association (NYHA) Class IV heart failure.
- •Uncontrolled abnormal bleeding and/or clotting disorder.
- •Contraindication to systemic or oral anticoagulation.
- •Presence of active intracardiac thrombus detected by imaging (pre-procedural via transesophageal echocardiogram (TEE) or transthoracic echocardiogram (TTE), CT, MRI, or intra-procedural via intracardiac echocardiography (ICE).
- •Ineligible for ablation according to physician judgement (including but not limited to hemodynamically unstable, prior interatrial patch, Amplatzer, etc.).
- •Serious or untreated medical conditions that would prevent participation in the study interfere with assessment or therapy, or confound data or its interpretation, including but not limited to solid organ or hematologic transplant, or currently being evaluated for an organ transplant.
- •Severe lung disease, pulmonary hypertension, or any lung disease involving abnormal blood gases or significant dyspnea at the time of enrollment.
- •Body Mass Index ≥
- •Chronic renal insufficiency of estimated glomerular filtration rate (eGFR) < 30 mL/min/1.73 m
- •Active malignancy.
- •Active systemic infection.
- •Life expectancy is less than one year.
- •Prohibitively distorted cardiac anatomy due to congenital heart disease.
- •Participation in another investigational study that may interfere with the procedure outcomes for this study unless pre-approved by sponsor.
- •Unable to understand the nature of this study or is unwilling or unable to attend all the study visits.
- •Pregnancy or planned pregnancy, lactating or any women of childbearing potential who is not on a reliable form of birth control.
研究组 & 干预措施
Field Force Pulsed Fiel Ablation
Participants will undergo ventricular tachycardia ablation using the Field Force Pulsed Field Ablation System during the index procedure.
干预措施: System is an investigational catheter-based device designed to deliver pulsed field ablation energy to cardiac tissue for the treatment of sustained monomorphic VT (Device)
结局指标
主要结局
Occurrence of causal or probable device or procedure related Major Adverse Events (MAEs) that occur within seven (7) days post-index procedure,
时间窗: 7 days and 90 Days
Occurrence of causal or probable device or procedure related Major Adverse Events (MAEs) that occur within seven (7) days post-index procedure will be assessed with the exception of esophago-pericardial fistula and/or esophageal perforation which will be assessed at the 90-day visit.
Freedom from recurrence of sustained monomorphic VT through 180 days following the index ablation procedure
时间窗: 180 days
Freedom from recurrence of sustained monomorphic VT through 180 days following the index ablation procedure, in the absence of initiation of a new Class I or III antiarrhythmic drug (AAD) prescribed for any ventricular arrhythmias, or an increase in dose of a pre-existing Class I or III antiarrhythmic drug (AAD) prescribed for any ventricular arrhythmias.
Primary Safety
时间窗: As applicable within 7 days or 90 days after the index ablation procedure
A pre-defined list of device - or procedure-related MAEs, as adjudicated by the Clinical Events Committee (CEC), occurring within 7 days after the index ablation procedure (or within 3 months after the index ablation procedure for any esophago-pericardial fistula/esophageal perforation) will be considered a primary safety event
Primary Effectiveness
时间窗: Through 6 months most the index ablation procedure
Freedom from recurrence of sustained monomorphic VT (MMVT) in the absence of new or increased dose of Class I or III antiarrhythmic drugs (AAD) for any ventricular arrhythmia through 6 months after the index ablation procedure
次要结局
- The reduction in sustained ventricular tachycardia burden captured through 180 days post ablation(180 days)
- Secondary Effectiveness Endpoint(6 months post index procedure)