NCT06703489招募中不适用
Safety and Performance Assessment of the Sphere-9™ Catheter and Affera™ Ablation System for the Treatment of Ventricular Tachycardia
Medtronic Cardiac Ablation Solutions10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2025年3月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Primary Safety Endpoint: evaluate the safety of the index ablation procedure
研究概览
简要总结
Sphere-9 VT EFS is a prospective, multi-center, non-randomized, unblinded feasibility study. Adult subjects with recurrent, sustained, scar-related monomorphic ventricular tachycardia will be enrolled and treated with the Sphere-9 Catheter and Affera Ablation System.
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
- •Any of the following:
- •Ischemic cardiomyopathy (ICM) patients with prior history of myocardial infarction (MI).
- •Non-ischemic cardiomyopathy (NICM) patients with documented myocardial scar in a territory without coronary stenosis as evidenced by cardiac imaging.
- •At least one episode of sustained (continuous for >30 seconds or requiring ICD intervention for termination) monomorphic ventricular tachycardia within the 6 months prior to enrollment.
- •Recurrence of sustained ventricular tachycardia despite class I or III antiarrhythmic drug therapy or ICD intervention.
- •Implanted with an implantable cardiac defibrillator (ICD) or CRT-D for at least 3 months prior to the ablation procedure.
- •Age 18 through 85 years old.
- •Willing and able to provide informed consent.
- •Willing and able to comply with all pre-, post-, and follow-up testing requirements.
排除标准
- •Incessant VT necessitating hemodynamic support prior to the ablation procedure.
- •Unstable polymorphic VT or ventricular fibrillation (VF).
- •VTs due to any of the following:
- •Idiopathic VT
- •Automaticity or triggered activity
- •Lamin or titin genetic mutation
- •Ventricular tachycardia secondary to electrolyte imbalance, active thyroid disease, or any other reversible or non-cardiac cause (e.g., drug induced arrhythmia).
- •NICM subjects with active inflammatory processes (e.g., myocarditis) within 120 days prior to the ablation procedure.
- •VT or VF thought to be from channelopathies.
- •More than two prior VT ablations at any time, more than one prior VT ablation within 12 months prior to the ablation procedure, or any VT ablation within 4 weeks prior to the ablation procedure.
- •Sarcoidosis.
- •Hypertrophic cardiomyopathy, except when due to an apical aneurysm.
- •Unstable angina.
- •Active myocardial ischemia.
- •Type 1 myocardial infarction within 2 months (60 days) prior to the ablation procedure.
- •Any percutaneous coronary intervention within 2 months (60 days) prior to the ablation procedure.
- •Any cardiac surgery within 3 months (90 days) prior to the ablation procedure.
- •Left ventricular ejection fraction (LVEF) <15%.
- •NYHA Class IV heart failure.
- •Decompensated heart failure.
- •Currently receiving support, or anticipated to receive support prior to the index ablation procedure, via extracorporeal membrane oxygenation (ECMO).
- •Ventricular assist device (VAD) implanted, planned or required for the procedure.
- •Severe aortic or mitral stenosis, or severe aortic or mitral regurgitation.
- •Presence of prosthetic valve in the aortic or mitral valve.
- •Patients with advanced COPD (on home oxygen).
- •Presence of intracardiac thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- •Thromboembolic event (stroke or transient ischemic attack) within 6 months (180 days) prior to the index ablation procedure or with neurologic deficit.
- •Left atrium (LA) or left ventricle (LV) intracardiac thrombus on imaging.
- •Severe bleeding, clotting or thrombotic disorder, or thrombocytopenia (defined as platelet count <80,000).
- •Contraindication to anticoagulation.
- •End-stage renal disease (requiring dialysis).
- •Acute illness, active infection, or sepsis.
- •Life expectancy less than 12 months.
- •Any woman known to be pregnant or breastfeeding, or any woman of childbearing potential who is not on a reliable form of birth regulation method or abstinence.
- •Body mass index >45 kg/m
- •Known ongoing drug or alcohol dependency.
- •Current or anticipated participation in any other ongoing study of a drug, device, or biologic during the duration of the study not pre-approved by the Sponsor.
- •Vulnerable subjects (such as a prisoner, handicapped or mentally disabled person, or person under tutelage or guardianship).
- •Any other condition that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would pose a significant hazard to the subject if an ablation procedure were performed.
研究组 & 干预措施
Ventricular tachycardia catheter ablation
Experimental
Ablation using the Sphere-9 Catheter with the Affera Mapping and Ablation System
干预措施: Sphere-9 Catheter with the Affera Mapping and Ablation System (Device)
结局指标
主要结局
Primary Safety Endpoint: evaluate the safety of the index ablation procedure
时间窗: Within 7 days post-procedure
Percentage of patients with device- or procedure-related cardiovascular- or pulmonary-related serious adverse events
Primary Effectiveness Endpoint: assess acute procedural success of the index ablation procedure
时间窗: Day of ablation procedure
Percentage of patients whose targeted clinically relevant monomorphic ventricular tachycardia cannot be induced
次要结局
- Secondary Endpoint: assess chronic effectiveness of the index ablation procedure(Within 6 months post-procedure)
研究者
研究点 (10)
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