SPHERE Per-AF Post-Approval Study, an Addendum to the Affera Global Registry
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 200
- 试验地点
- 20
- 主要终点
- Primary Safety Objective
研究概览
简要总结
SPHERE Per-AF Post-Approval Study is a prospective, multi-center, non-randomized, observational trial. Subjects will be treated with the Sphere-9™ Catheter and Affera™ Ablation System and followed through 36 months.
详细描述
The purpose of the study is to evaluate the long-term effectiveness and safety of the Sphere-9™ Catheter and Affera™ Ablation System in a post-approval setting for the treatment of drug refractory, recurrent, symptomatic, persistent AF (episode duration less than one year).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •A diagnosis of recurrent symptomatic persistent AF (continuous AF sustained longer than 7 days but less than 12 months)
- •Refractory (i.e. not effective, not tolerated, or not desired) to at least one Class I or III antiarrhythmic drug (AAD)
- •Patient is ≥ 18 years of age
- •Planned de novo pulmonary vein isolation procedure using commercially available Sphere-9™ Catheter and Affera Ablation System
- •Patient is willing and able to comply with study requirements and give informed consent
排除标准
- •Long-standing persistent AF (continuous AF sustained >12 months)
- •Prior left atrial catheter or surgical ablation
- •Life expectancy <36 months
- •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)
- •Current or anticipated participation in any other clinical trial of a drug, device or biologic during the duration of this study not pre-approved by Medtronic
研究组 & 干预措施
Persistent Atrial Fibrillation
干预措施: Sphere-9™ Catheter and Affera™ Ablation System (Device)
结局指标
主要结局
Primary Safety Objective
时间窗: Through 180 days Post-Procedure
Estimate the primary safety adverse event (AE) rate for ablation using the Sphere-9™ Catheter and Affera™ Ablation System.
Primary Effectiveness Objective
时间窗: Through 36 months Post-Procedure
Estimate the 36-month freedom from atrial fibrillation (AF), atrial tachycardia (AT) or atrial flutter (AFL) recurrence following ablation procedure using the Sphere-9™ Catheter and Affera™ Ablation System.
次要结局
未报告次要终点