Horizon 360 Protocol for the Treatment of Paroxysmal Atrial Fibrillation With the Prospective, Single Arm, Unblinded Pre-market Clinical Study to Evaluate the Safety and Effectiveness of the Sphere-360 Catheter and Affera Mapping and Ablation System for Treating Paroxysmal Atrial Fibrillation (PAF)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 48
- 主要终点
- Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation
研究概览
简要总结
The study is a prospective, single-arm, pre-market clinical study and will enroll up to 300 subjects at up to 26 sites in the United States (US) for analysis of primary objectives. No single site may contribute more than 15% of the enrollments.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of recurrent symptomatic PAF, which is defined as continuous AF episode lasting longer than 30 seconds but terminates spontaneously or with intervention within 7 days of onset, documented by the following:
- •a physician's note indicating at least 2 symptomatic PAF episodes occurring within 6 months prior to enrollment; and
- •at least 1 electrocardiographically documented episode within 12 months prior to enrollment
- •Adults who are ≥18 and ≤80 years of age on the day of enrollment.
- •Willing and able to comply with all baseline and follow-up evaluations for the full length of the study.
排除标准
- •Continuous AF lasting more than 7 days. This includes persistent atrial fibrillation (PsAF) (both early or long-standing) by diagnosis or continuous duration > 7 days
- •AF that required three (3) or more distinct cardioversions in the preceding 12 months.
- •LA anteroposterior > 5.0 cm (by MRI, CT, or TTE)
- •Any of the following procedures, implants, or conditions at baseline: prior left atrial catheter or surgical ablation, prior left atrial percutaneous interventions including left atrial appendage occlusion, and septal closure devices
- •Planned LAA closure procedure or implant of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function) for any time during the follow-up period
- •Patient who is not on oral anticoagulation therapy for at least 3 weeks prior to the ablation procedure
- •Presence of a permanent pacemaker, biventricular pacemaker, loop recorder/insertable cardiac monitor (ICM), or any type of implantable cardiac defibrillator (with or without biventricular pacing function)
- •Presence of any pulmonary vein stents
- •Known pre-existing pulmonary vein stenosis
- •Pre-existing hemidiaphragmatic paralysis
- •Prior valvular (surgical or percutaneous) procedure including prosthetic, bioprosthetic, valve replacement, valve repair or valvuloplasty, and any prior atriotomy
- •Moderate to severe aortic or mitral valve stenosis
- •Moderate to severe mitral regurgitation (i.e., 3+ or 4+ MR)
- •Any cardiac surgery, myocardial infarction, PCI / PTCA or coronary artery stenting which occurred during the 3-month interval preceding the consent date
- •Unstable angina
- •NYHA Class III or IV congestive heart failure or documented left ventricular ejection fraction (LVEF) less than or equal to 40% measure by acceptable cardiac testing (e.g. TTE), or planned transplant or left ventricular assist device (LVAD)
- •Severe lung disease, primary pulmonary hypertension, or any lung disease with abnormal blood gases or requiring supplemental oxygen
- •Rheumatic heart disease
- •Severe thrombocytosis, thrombocytopenia, or any bleeding or clotting disorder
- •Contraindication to or unwillingness to use systemic anticoagulation
- •Documented left atrial thrombus on imaging
- •Active systemic infection or sepsis
- •Hypertrophic cardiomyopathy
- •Known reversible causes of AF, including but not limited to uncontrolled hyperthyroidism, severe untreated obstructive sleep apnea, and acute alcohol toxicity
- •Any cerebral ischemic event (strokes or TIAs) which occurred during the 6-month interval preceding the consent date
- •Carotid stenting or endarterectomy
- •History of thromboembolic event within the past 6 months or evidence of intracardiac thrombus at the time of the procedure
- •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
- •Patient with life expectancy that makes it unlikely 12 months of follow-up will be completed
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of the study not pre-approved by Medtronic
- •Known allergies or hypersensitivities to adhesives
- •Body mass index > 40 kg/m2
- •Atrial myxoma
- •Significant restrictive or obstructive pulmonary disease or chronic respiratory condition.
- •Renal insufficiency with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m2, or any history of renal failure requiring dialysis or renal transplant
- •Solid organ or hematologic transplant, or currently being evaluated for an organ transplant
- •Presence of intramural thrombus, tumor, or other abnormality that precludes vascular access, catheter introduction, or manipulation
- •Known drug or alcohol dependency
- •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.
- •Treatment with Amiodarone within the 3 months prior to enrollment
- •Amyloid heart disease (cardiac amyloidosis)
研究组 & 干预措施
Pulmonary Vein Isolation Ablation
Pulmonary Vein Isolation Ablation utilizing the Sphere-360 and Affera Mapping and Ablation System
干预措施: Sphere-360 Pulsed Field Ablation Catheter with the Affera Mapping and Ablation System (Device)
结局指标
主要结局
Freedom from Atrial Tachyarrhythmia Recurrence Through 12 Months Post-Ablation
时间窗: Index ablation procedure through 12 months of follow up.
Freedom from documented recurrence of atrial fibrillation, atrial tachycardia, or atrial flutter based on electrocardiographic data through 12 months (365 days) and excluding a 90-day blanking period. The study requires 24-hour Holter monitoring at 6 and 12 months in addition to weekly and symptomatic trans-telephonic monitoring (TTM) transmissions through 12 months, and 12-lead ECGs at all follow up visits. Atrial tachyarrhythmia observed via any of those instruments, as well as acute procedural failure, repeat ablation, cardioversion, an increase in anti-arrhythmic drugs, or use of amiodarone at any time during the study will constitute a failure.
Incidence of Device- and Procedure-Related Serious Adverse Events Through 6 Months
时间窗: Index ablation procedure through 6 months of follow up.
Primary safety events (device- and procedure-related serious adverse events, as adjudicated by the Clinical Events Committee) for the Sphere-360 Catheter and Affera Mapping and Ablation System: Within 7 days: heart block, major bleeding needing transfusion, MI, permanent phrenic nerve paralysis, pulmonary edema, severe pericarditis, significant effusion/tamponade, stroke/CVA, systemic/pulmonary embolism needing intervention, TIA, vagal nerve injury causing esophageal dysmotility/gastroparesis, vascular access complications needing intervention, AKI needing dialysis or hospitalization \>48h or prolonged \>48h, death, any device/procedure-related CV/pulmonary event causing/prolonging hospitalization \>48h (excludes recurrent AF/AT/AFL). Within 3 months: atrioesophageal/esophago-pericardial fistula, esophageal perforation (device/procedure related; excludes TEE/nasogastric tube injury). Within 6 months: pulmonary vein stenosis (≥70% diameter reduction).
次要结局
- Secondary Endpoint: Quality of Life (AFEQT)(Index ablation procedure through 12 months of follow up.)
- Secondary Endpoint: Quality of Life (EQ-5D)(Index ablation procedure through 12 months follow up.)