EPX-HTG for Structural Heart Procedures

Condition(s) studied

Investigational drug(s) / intervention(s)

Left Atrial Appendage Occlusion: Left Atrial Appendage Occlusion with HTG as an additive visualization tool for procedure guidance.

Mitral Valve Transcatheter Edge to Edge Repair: Mitral Valve Transcatheter Edge to Edge Repair with HTG as an additive visualization tool for procedure guidance.

Study 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.

Eligibility

Primary outcome measure(s)

• Optimal Device Position. — 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.

Trial sites (1)

Other trials for the same condition