EchoPixel Holographic Therapy Guidance (HTG) for Structural Heart Procedures
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Optimal Device Position.
研究概览
简要总结
To investigate and evaluate the benefits of adding EchoPixel Holographic Therapy Guidance to the current standard of care in Structural Heart (SH) procedures.
Current structural heart (SH) procedures rely on standard image guidance (SIG) relies on 2D X-plane or multiplanar reformatted (MPR) views that can conceal critical anatomy elements at the time of implant or therapy delivery which are crucial to achieve an optimal long term durable outcome.
This limitation complicates an operator's task of optimally implanting a 3D device, delivered by tools that rotate and maneuver in 3D, within a dynamic 3D anatomy, the heart. Slight mismatches between the device and the target in the heart are indicative of a sub-optimal device position, a key risk-factor of peri-device leak (PDL) and other complications.
The primary objective of the study is to determine if including EchoPixel - HTG as an additive visualization procedural tool has a positive impact on optimal procedure outcomes for patients undergoing in Structural Heart (SH) procedures.
详细描述
A prospective, single-center, clinical chart review.
In this trial, we will determine if the additional use of EchoPixel - HTG demonstrates a reduction in procedure time, decrease use of contrast and radiation, minimize the number of devices trialed during a procedure, determine ideal fluoroscopic viewing angles for device deployment, and optimize implant deployment and seal in in Structural Heart (SH) procedures.
The study team will compile the redacted pre- procedure CT, redacted procedural Trans-Esophageal Echo (TEE) or Intra-Cardiac Echo (ICE), procedural fluoroscopic imaging and the post device implant imaging created for each procedure case. Patient health information will be redacted and provided to physicians for review. Data will be collected on case report forms.
A prospective review will occur of outcomes regarding the Structural Heart (SH) procedure cases and data will be recorded on case report forms to compare to normal historical outcomes.
All available consecutive patients treated with the Watchman FLX device for Left Atrial Appendage Occlusion (LAAO) or MitraClip for Mitral Valve transcatheter edge to edge repair (M-TEER) will be reviewed. The primary endpoint will be to determine if EchoPixel - HTG assists in better guiding the implanter during the procedure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients 18 and older scheduled for LAAO or M-TEER at the study site and whose procedure will use Philips CVx TEE or 3D ICE.
排除标准
- •Patients whose procedures would require a GE or Siemens ultrasound system.
结局指标
主要结局
Optimal Device Position.
时间窗: 45 days post procedure.
For both LAAO and M-TEER procedures an optimal device position will be established in pre-procedure planning. The optimal device position will be evaluated at the time of the procedure and in post-procedure imaging.
次要结局
- Procedure Time.(Perioperative/Periprocedural measurement of procedure length/duration.)
- Fluoroscopic Time.(Perioperative/Periprocedural measurement of length/duration of fluoroscopy use.)
- Radiation Dose.(Perioperative/Periprocedural measurement of total radiation dose for completing procedure/surgery.)
- Contrast Used.(Perioperative/Periprocedural measurement of total radio-opaque contrast used for completing procedure/surgery.)
- Number of devices trialed for procedure completion.(Perioperative/Periprocedural count of the total number of devices (LAAO or TEER) utilized/required to complete the procedure/surgery.)
- Number of Device Deployments.(Perioperative/Periprocedural count of the total number of times a device is positioned for final deployment in order to be released from the delivery catheter in order to complete the procedure/surgery/)
- Procedure-related complications.(Perioperative/Periprocedural and throughout 45-day follow-up visit.)