DURABLE-I Study: Dielectric Unravelling of Radiofrequency ABLation Effectiveness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
研究概览
简要总结
The purpose of this study is to evaluate real-time gap detection using EPD D700 dielectric sensing compared with customary electrical isolation tests and Adenosine infusion at the end of the procedure. Furthermore, safety, usability and clinical applicability of the system for guided AF ablation will be confirmed.
详细描述
Prospective, single-center, non-randomized, non-blinded, open label, and single arm study.
All procedures will be performed under CARTO-3 guidance for the treatment of atrial fibrillation (AF). The EPD D700 system will be used in-tandem, to record pre-, during and immediate post-ablation tissue characteristics and compute likelihood of lesion transmurality and permanency. Additionally, D700 system safety, feasibility, usability and clinical applicability will be documented.
The entire procedure will be conducted as customary, using standard and approved off-the-shelf equipment (body surface electrodes, diagnostic and irrigated ablation catheters, RF generator and recording system), in a completely clinically independent manner from the EPD D700 system. The physician will neither use nor rely on any of the D700 system output for clinical decision making and will be blinded to the D700 lesion assessment forecasts. After 30 days following the initial procedure, a repeated procedure will be performed for gap detection and its results will be correlated with the D700 predictions.
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
- •Male or female patients, age ≥ 18 and ≤ 80 years.
- •Paroxysmal atrial fibrillation (PAF)
- •Able to provide written informed consent form to participate in the study, prior to any study related procedures.
- •Able and willing to comply with the study protocol requirements.
- •A female subject is eligible if not of child bearing potential or has a negative pregnancy test within the previous 7 days.
排除标准
- •Any planned surgical or endovascular intervention within 30 days before or after the index procedures.
- •Subject is enrolled in another drug or device study protocol that has not reached its primary endpoint.
- •Previous AF ablation therapy.
- •Clinical evidence of active coronary ischemia, significant Valvular heart disease, or hemodynamically significant congenital cardiac abnormality.
- •Patient had experienced myocardial infarction (MI), stroke (CVA) or transient ischemic attack (TIA) or other neurological disturbances.
- •Patient has a pacemaker.
- •Thrombi detected in the heart.
- •Life expectancy less than 12 months.
- •Known severe renal insufficiency.
- •Known allergy to Iodine.
研究组 & 干预措施
D700 System
Patients referred to catheter-based Atrial-Fibrillation (AF) ablation procedure therapy comprising of Pulmonary Veins Isolation (PVI).
干预措施: D700 System (Device)
结局指标
主要结局
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
时间窗: 30 days
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy. All patients underwent PVI at index procedure. The physicians were blinded to the D700 (KODEX-EPD) ETA function pairwise real-time lesion assessment readings. All patients were restudied at 1-mont, and ETA reading, which is the number of gaps as predicted by the system, were compared to the actual gaps as validated in the second procedure after one month.
1-month Patient Analysis
时间窗: 30 days
ETA Reading at Index Procedure vs. Actual Gaps at 1-month Restudy
次要结局
未报告次要终点