A Retrospective Multicenter Post-Market Clinical Follow-up Registry Comparing Safety and Effectiveness Outcomes of Epicardial Cardiac Ablation Using Remote Navigation to Manual Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Stereotaxis
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Procedural Safety: rates of device-and procedure-related serious adverse events
研究概览
简要总结
Retrospective registry will compare subjects who've undergone a mapping and/or ablation procedure for either ischemic ventricular tachycardia or premature ventricular contraction using an epicardial approach with either manual or remote magnetic navigation. Subjects will be compared with regards to safety, efficacy and mortality.
详细描述
Up to 10 centers in the European Union will be selected to conduct the trial. Once a site is a selected, receives local Ethics Committee approval, and receives Sponsor approval to enroll, the site will begin enrollment. All subjects must meet eligibility criteria and follow protocol and ethics committee requirements regarding informed consent prior to enrollment. Once a subject is enrolled, the site may begin reviewing the subject's medical records and entering data into the electronic data capture system. Once enrollment and retrospective data entry is complete at a site, a monitoring visit will occur where source data verification will occur.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •18 years of age or older
- •Have undergone an epicardial RF mapping and/or ablation for a ventricular tachycardia (VT) as standard of care treatment using either the Niobe MNS or a manual approach
- •Index procedure was conducted between July 1, 2013-present date.
排除标准
- •NA, all subjects who meet inclusion criteria may be enrolled.
结局指标
主要结局
Procedural Safety: rates of device-and procedure-related serious adverse events
时间窗: 48 hours post index procedure
Assess rates of device-and procedure-related serious adverse events in both groups.
Acute Success
时间窗: intra-operative
Characterize acute success rates for both groups. Acute success for VT procedures is defined as non-inducibility of clinical VT and/or other monomorphic VT at the end of the index-procedure. Acute success for PVC procedures is defined as no recurrence and non-inducibility of culprit PVC at the end of the index-procedure.
次要结局
- Mortality(1 year post index procedure)
- Chronic Safety: rates of device-or procedure-related serious adverse events(At last follow up visit, estimated up to 6 years post-procedure for some patients)
- Chronic Success(At last follow up visit, estimated up to 6 years post-procedure for some patients)