Registry Evaluating AF Ablation Techniques
赞助:
Erasmus Medical Center
合作者:
信息的提供 (责任方):
Anne-Marie Noten，Erasmus Medical Center
| 追踪信息 | |||
|---|---|---|---|
| 首次提交日期 ICMJE | September 20, 2018 | ||
| 首次发布日期e ICMJE | October 4, 2018 | ||
| 最后更新发布日期 | October 4, 2018 | ||
| 预计研究开始日期 ICMJE | October 1, 2018 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 目前主要观察指标 ICMJE |
Procedure time[ Time Frame: During ablation procedure ] Procedure time (minutes) Fluoroscopy time[ Time Frame: During ablation procedure ] Fluoroscopy time (minutes) Transseptal time[ Time Frame: During ablation procedure ] Transseptal time (time from insertion of catheters until transseptal puncture) (minutes) Left atrial dwell time[ Time Frame: During ablation procedure ] Left atrial dwell time (time from LA entry until removal of catheters) (minutes) PVI ablation time[ Time Frame: During ablation procedure ] PVI ablation time (total PVI ablation time, i.e. first until last application) (minutes) Ablation time per pulmonary vein[ Time Frame: During ablation procedure ] Ablation time per pulmonary vein (minutes) |
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| 原始主要观察测量 ICMJE | 与当前相同 | ||
| 目前的二级观察 ICMJE |
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| 描述性信息 | |||
| 简略标题 ICMJE | Registry Evaluating AF Ablation Techniques | ||
| 正式标题 ICMJE | Prospective, Multicenter, Non-randomized Observational Registry Conducted at High Volume Experienced Treatment Centers Utilizing the Most Current AF Ablation Techniques. | ||
| 简要概况 | The purpose of this observational registry is to prospectively collect procedure efficiency, safety and acute and long term outcome data from catheter ablation procedures as treatment of paroxysmal atrial fibrillation, using the following treatment modalities: - Cryoballoon ablation - Manual guided RF ablation using Contact Force catheters - Remote Magnetic Navigation guided RF ablation with e-Contact and high power settings - Remote Magnetic Navigation guided RF ablation with e-Contact and low power settings |
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| 详细说明 | |||
| 研究类型 ICMJE | Observational [Patient Registry] | ||
| 研究阶段 | |||
| 研究设计 ICMJE | 分配: 干预模型: 干预模型描述: 盲法: Observational [Patient Registry] 盲法描述: 主要目的: |
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| 适用条件 ICMJE | |||
| 干预项目 ICMJE |
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| 研究工具 |
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| 招募信息 | |||
| 招募状态 ICMJE | Not yet recruiting | ||
| 预计入组 ICMJE |
600 | ||
| 原始预计入组 ICMJE | 与当前相同 | ||
| 预计研究完成日期 | October 2022 | ||
| 预计主要完成日期 | October 2019 (主要结果测量的最终数据收集日期) | ||
| 合格标准 ICMJE | Inclusion Criteria: - Documented Paroxysmal Atrial Fibrillation - Eligibility for Pulmonary Vein Isolation by catheter ablation based on the respective ACC/AHA/ESC Guideline valid at the date of procedure - Signed the informed consent to participate in the registry Exclusion Criteria: - Younger than 18 years of age - Prior AF ablation procedure (including MAZE procedure) - Prior ablation of Non-AF Arrhythmia within 3 months of enrollment - Presence of cardiac thrombus - Other AF ablations performed during procedure (e.g. lines, rotor, CFAE's etc) - Active endocarditis or systemic infection - Life expectancy < 1 year - Pregnancy | ||
| 性别 |
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| 年龄 | 最小年龄：18 Years ，最大年龄：N/A | ||
| 接受健康的志愿者 | 没有 | ||
| 可入组国家 ICMJE | |||
| 管理信息 | 数据检测委员会 | No | |
| 研究涉及美国FDA监管的产品 |
研究美国FDA监管的药品: No 研究涉及美国FDA监管的设备产品: No |
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| IPD 共享声明 |
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| 责任方 | Anne-Marie Noten，Erasmus Medical Center | ||
| 研究赞助商 ICMJE | Erasmus Medical Center | ||
| 合作者 ICMJE | |||
| 研究员 ICMJE |
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| PRS 账户 | Erasmus Medical Center | ||
| 验证日期 | October 2018 | ||
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ICMJE 国际医学期刊编辑委员会和 世界卫生组织 ICTRP 要求的元素 |
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