EPX-HTG for Structural Heart Procedures

Starting soon · Not applicable

Conditions studied: Atrial Fibrillation (AF), Mitral Valve (MV) Regurgitation

In brief

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.

Key facts

Study ID

NCT07705425

Run by

EchoPixel, Inc.

People needed

20

Starts

2026-08-03

Expected to finish

2027-10-30

Last updated by the study team

2026-07-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Patients whose procedures would require a GE or Siemens ultrasound system.

Where it is running

• University of California, Davis — Sacramento, California, United States

Full record on ClinicalTrials.gov

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