NCT07651852尚未招募不适用
Globe Registry: Globe® Pulsed Field System Registry Study for Treating Patients With Symptomatic Atrial Fibrillation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- Kardium Inc.
- 入组人数
- 500
- 主要终点
- Effectiveness endpoint
研究概览
简要总结
This post-market registry is designed to collect real world data on the use of the Globe PF System for the treatment of atrial fibrillation (AF).
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
- •Patients with a planned ablation procedure using the commercially available Globe PF System
排除标准
- •Patients whose life expectancy is 1 year or less
- •Contraindication to left atrial catheter ablation or PF ablation
- •Current enrollment in any investigational study of a medical device, biologic, or drug not pre-approved by Kardium
研究组 & 干预措施
Globe Pulsed Field System
干预措施: Globe Pulsed Field System (Device)
结局指标
主要结局
Effectiveness endpoint
时间窗: 12 months
Rate of 12-month treatment success following ablation using the Globe PF System.
Safety endpoint
时间窗: 7 days
Rate of subjects with one or more major adverse events up to 7 days following the index ablation procedure.
次要结局
未报告次要终点
研究者
相似试验
尚未招募
不适用
The EMBRACE Registry: European Post-Market Registry for Catheter Based Mitral Valve ReplacementMitral RegurgitationNCT07409285HighLife SAS150
尚未招募
不适用
Global Utilization And Registry Database for Improved preservAtion of doNor Pancreata (GUARDIAN-PANCREAS)Pancreas Transplant ComplicationsNCT07487194Paragonix Technologies1,000
尚未招募
不适用
The FLOW Registry.NCT07430423University of Chicago3,000
Enrolling By Invitation
不适用
VitaSmart HOPE System: Bridge to HOPE RegistryLiver FailureNCT07578441Bridge to Life Ltd.5,000
招募中
不适用
Prospective Evaluation of the Pulse Biosciences nPulse™ Vybrance™ Percutaneous Electrode SystemThyroid NoduleNCT07287176Pulse Biosciences, Inc.100