A Safety and Performance Assessment of the SpherePVI™ Catheter and the Affera Mapping and Ablation System to Treat Paroxysmal Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Percentage of subjects experiencing a primary safety event
研究概览
简要总结
A prospective, single-arm, single-center study to evaluate the safety, performance, and effectiveness of the SpherePVI™ Catheter for treating paroxysmal AF.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Symptomatic paroxysmal or persistent atrial fibrillation documented by:
- •A physician's note indicating recurrent AF
- •At least two electrocardiographically documented AF episodes within 12 months prior to enrollment
- •Failure or intolerance of at least one Class I-IV anti-arrhythmic drug.
- •Suitable candidate for catheter ablation.
- •Age ≥ 18 and < 75 years.
- •Able and willing to give informed consent.
- •Able and willing, and has ample means to comply with all pre-procedure, post-procedure and follow-up testing requirements
排除标准
- •Subjects will not be eligible for the study if any of the following criteria are met:
- •Continuous AF lasting more than 12 months (long-standing persistent AF).
- •AF secondary to electrolyte imbalance, thyroid disease, acute alcohol intoxication, or reversible or non-cardiac cause.
- •Previous left atrial catheter or surgical ablation (including septal closure or left atrial appendage closure).
- •Valvular cardiac surgical/percutaneous procedure (e.g., ventriculotomy, atriotomy, and valve repair or replacement and presence of a prosthetic valve).
- •Any carotid stenting or endarterectomy.
- •Any cardiac procedure (surgical or percutaneous) or percutaneous coronary intervention within 90 days prior to the initial procedure.
- •Coronary artery bypass graft (CABG) procedure within the 6 months prior to the index ablation procedure.
- •Awaiting cardiac transplantation or other cardiac surgery within 12 months following the initial ablation procedure.
- •Presence of any type of implantable cardiac defibrillator (with or without biventricular pacing function).
- •Documented thromboembolic event (stroke or transient ischemic attack) within the past 6 months (180 days).
- •Documented left atrial thrombus on imaging.
- •History of blood clotting or bleeding abnormalities.
- •Any condition contraindicating chronic anticoagulation.
- •Myocardial infarction (MI) within the 3 months (90 days) prior to the initial procedure.
- •Body mass index >40 kg/m
- •Left atrial diameter (anteroposterior) >50 mm for paroxysmal AF and >55mm for persistent AF.
- •Diagnosed atrial myxoma.
- •Left ventricular ejection fraction (EF) < 40%.
- •Uncontrolled heart failure or NYHA Class III or IV heart failure.
- •Rheumatic heart disease.
- •Hypertrophic cardiomyopathy.
- •Unstable angina.
- •Moderate to severe mitral valve stenosis.
- •Severe mitral regurgitation (regurgitant volume ≥ 60 mL/beat, regurgitant fraction ≥ 50%, and/or effective regurgitant orifice area ≥ 0.40cm2).
- •Primary pulmonary hypertension.
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- •Renal failure requiring dialysis.
- •Acute illness, active systemic infection, or sepsis.
- •Significant congenital anomaly or medical problem that, in the opinion of the investigator, would preclude enrollment in this study or compliance with follow-up requirements or would impact the scientific soundness of the clinical trial results.
- •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.
- •Current or anticipated participation in any other clinical trial of a drug, device, or biologic during the duration of the study, unless pre-approved by the Sponsor.
- •Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation.
- •Known drug or alcohol dependency.
- •Life expectancy less than 12 months.
- •Vulnerable subject.
研究组 & 干预措施
SpherePVI™ Catheter
Subjects treated with the SpherePVI™ Catheter
干预措施: SpherePVI™ Catheter (Device)
结局指标
主要结局
Percentage of subjects experiencing a primary safety event
时间窗: Up to 6 months
The primary safety outcome is the incidence of the following serious device-related Primary Adverse Events (AEs): * Death (within 7 days) * Myocardial infarction (within 7 days) * Persistent phrenic nerve palsy (within 7 days) * Transient ischemic attack (TIA) (within 7 days) * Stroke/cerebrovascular accident (CVA) (within 7 days) * Thromboembolism (within 7 days) * Major vascular access complications / bleeding (within 7 days) * Heart block (within 7 days) * Gastroparesis (within 7 days) * Severe pericarditis (within 7 days) * Pulmonary edema (within 7 days) * Hospitalization (initial and prolonged) due to cardiovascular or pulmonary AE (within 7 days) * Cardiac tamponade / perforation (within 30 days) * Pulmonary vein stenosis (within 180 days) * Atrio-esophageal fistula (within 180 days)
Percentage of subjects with acute procedure success
时间窗: During Procedure
The primary efficacy outcome is acute electrical isolation of all pulmonary veins using the study device. Acute electrical isolation of all pulmonary veins is defined as confirmation of entrance block in all targeted pulmonary veins.
次要结局
- Percentage of subjects free from documented recurrence outside of the blanking period(12 months)
- Percentage of subjects experiencing a device- or procedure-related SAE(12 months)
- Product performance evaluated on a 5-point semi-quantitative scale ("strongly disagree" to "strongly agree")(During Procedure)
- Percentage of pulmonary veins remaining isolated at remapping(75 days)