EchoPixel Holographic Therapy Guidance (HTG) for Structural Heart Procedures
EchoPixel, Inc.
Summary
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.
Description
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 pos…
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * 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. Exclusion Criteria: * Patients whose procedures would require a GE or Siemens ultrasound system.
Interventions
- DeviceLeft Atrial Appendage Occlusion
Left Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance.
- DeviceMitral Valve Transcatheter Edge to Edge Repair
Mitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance.
Location
- University of California, DavisSacramento, California