National Longitudinal Registry for Mid-Term Clinical Outcome And Procedure Efficacy Evaluation In Using A Novel Preprocedural Planning Method For Left Atrial Appendage Occlusion Guided By 3D Printing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- operating time
研究概览
简要总结
Left atrial appendage closure (LAAC) was approved by the ESC guidelines as a stroke prevention alternative to warfarin for patients with nonvalvular atrial fibrillation in patients at high risk of bleeding (IIbB).
Although the overall LAAC benefice, in term of prevention of stroke or embolisme and decresing the anticoagulant-related risk of bleeding is already demonstrated, however the procedure success and safety, critically depends on understanding LAA anatomy and adequate pre-procedure planning.
3D-printed patient-specific adaptive and flexible LA models have demonstrated in a previous study an improving in LAAO device sizing, a better pre-procedural planning of the optimal trans-septal puncture site, by incorporating all anatomical variations and an improuving patient outcomes by reducing procedure time and number of prostheses employed per patient.
This technique is now used in several surgical centers in France and large prospective evaluation of the practice is necessary.
详细描述
The 3D printing has modified the LAAC practices with a preoperative time allowing an optimal preparation of the prosthesis. This technique is now used in several surgical centers and prospective evaluation of the practice is necessary.
The objective of our research is to demonstrate the reduction of the operating time and number of prosthesis used per procedure when prior LAAC simulation testing and sizing is made on a 3D printed model.
It is therefore a longitudinal research to monitor professional practices for the evaluation of a new preoperative approach.
Procedures guided by 3Dprinted models will be compared (intention to treat population) in term of procedural parameters (procedure time, success rate, number of prosthesis per procedure) and procedural complication with prior Watchman study: post-FDA Approval US experience and national registries data. A second analysis (per protocol population) will be performed to compare patients with an informative utilization guided by 3D printed to those of the post-FDA Approval US experience and national registries.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •non valvular AF
- •adressed for LAAC procedure
排除标准
- •opposition from patients
结局指标
主要结局
operating time
时间窗: During 1 day
mesure of operating time to Day 0 (J0)
number of protheses
时间窗: During 1 day
decrease number of prothèses to Day 0 (J0)
Implantation success rate
时间窗: During 1 day
increase implantation success rate at Day 0 (J0)
次要结局
- Effective complete occlusion of the auricle(6 months)
- anasthesia time(During 1 day)
- time of scopy(During 1 day)
- irradiation dose(1 day)
- number of recapture(During 1 day)
- prosthesis trombosis(12 months)
- number of periprosthetic leak(During 1 day)
- Days of Hospitalisation(During 1 day)
- number of off-axis prostheses(During 1 day)
- number of embolized prostheses(During 1 day)
- procedural complications(during procedure and within 30 days)
- complication(6 and 12 months)