PROOF: Evaluating the Performance of the KODEX-EPD CRyOballoon Occlusion Feature in Patients With Atrial Fibrillation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 63
- 试验地点
- 2
- 主要终点
- Freeze success of the KODEX-EPD Occlusion Viewer
研究概览
简要总结
Prospective, multi-center, non-randomized, open label, double arm study to assess the performance of the KODEX-EPD PV occlusion viewer. This study includes patients with atrial fibrillation who are scheduled to undergo a cryo balloon ablation procedure for their atrial fibrillation.
详细描述
The study is designed to evaluate the performance of the KODEX-EPD occlusion viewer using a standardized workflow in a blinded setting in a homogenous patient group. Furthermore, in an effort to minimize therapy, a direct comparison between the success of the freeze when initiating therapy based on the occlusion viewer vs the assessment of occlusion assessed with fluoroscopy will be evaluated. The study design indicates a post-market interventional clinical investigation to evaluate the endpoints of the study. No follow-up is foreseen ensuring a minimal burden to the subjects participating in the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be aged >18 years.
- •Subject must have signed a written Informed Consent form to participate in the study, prior to any study related procedures.
- •Subject must be willing to comply with the protocol requirements.
- •Subject receives a de novo ablation procedure for treatment of atrial fibrillation.
排除标准
- •Pregnant women.
结局指标
主要结局
Freeze success of the KODEX-EPD Occlusion Viewer
时间窗: up to approximately 6 months
The success of the freeze when freeze is initiated based on the assessment of the KODEX-EPD PV occlusion feature as compared to the success of the freeze when freeze is initiated based on the assessment with fluoroscopy and contrast dye.
Effectiveness of the KODEX-EPD Occlsuion Viewer
时间窗: up to approximately 6 months
The primary effectiveness endpoint is the accuracy, sensitivity, specificity and positive and negative predictive values of the KODEX-EPD PV occlusion feature as compared to conventional angiographic method of fluoroscopy with contrast dye that will be used to guide the procedure.
次要结局
未报告次要终点