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NOT YET RECRUITING
NCT07705425
NA

EPX-HTG for Structural Heart Procedures

Sponsor: EchoPixel, Inc.

View on ClinicalTrials.gov

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.

Official title: EchoPixel Holographic Therapy Guidance (HTG) for Structural Heart Procedures

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2026-08-03

Completion Date

2027-10-30

Last Updated

2026-07-15

Healthy Volunteers

No

Interventions

DEVICE

Left Atrial Appendage Occlusion

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

DEVICE

Mitral Valve Transcatheter Edge to Edge Repair

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

Locations (1)

University of California, Davis

Sacramento, California, United States